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Coronavirus (COVID-19) Update: Daily Roundup April 28, 2020

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Coronavirus (COVID-19) Update: Daily Roundup April 28, 2020

April 28, 2020: “The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • Today, the FDA issued a new video resource external Link Disclaimer explaining Emergency Use Authorizations (EUAs), one of several tools FDA uses to help make important medical products available quickly during public health emergencies like the COVID-19 pandemic.

    As the videoExternal Link Disclaimer explains, EUAs provide more timely access to drugs, diagnostic tests and/or other critical medical products that can help diagnose, treat and/or prevent COVID-19.
    When deciding whether to issue a EUA, the FDA evaluates the available scientific evidence very quickly and carefully balances any known and potential benefits and/or risks of these products to the public.
  • The FDA and Federal Trade Commission (FTC) issued warning letters to two companies for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers.
    There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
    • The first seller warned, Hopewell Essential Oils, offers essential oils and herbal products for sale in the U.S. with misleading claims that the products are safe and/or effective for the prevention and treatment of COVID-19.
    • The second seller warned, Santiste Labs LLC, the “DefendTM Patch,” a transdermal patch containing a “composition of botanical oils,” for sale in the U.S. with misleading claims that the product is safe and/or effective for the prevention or treatment of COVID-19.
  • As part of its work to help protect public health, FDA updated its FAQ page with information about smoking and COVID-19. Smoking cigarettes can leave smokers more vulnerable to respiratory illnesses such as COVID-19, which is why there’s never been a better time to quit smoking. FDA’s Every Try Counts campaign has supportive tips and tools to help smokers get closer to quitting for good.
  • Today, the FDA posted information and resources to assist manufacturers submitting generic drug applications with bioequivalence studies that may be impacted during COVID-19.
  • Diagnostics update to date:
    • During the COVID-19 pandemic, the FDA has worked with more than 380 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
    • To date, the FDA has issued 50 individual emergency use authorizations for test kit manufacturers and laboratories. In addition, 22 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
    • The FDA has been notified that more than 230 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
    • The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-28-2020

ERYTECH Granted U.S. FDA Fast Track Designation for eryaspase in Second-Line Pancreatic Cancer

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ERYTECH Granted U.S. FDA Fast Track Designation for eryaspase in Second-Line Pancreatic Cancer

April 28, 2020: “ERYTECH Pharma announced that the U.S. FDA has granted eryaspase Fast Track Designation for the development of a second-line treatment of patients with metastatic pancreatic cancer.

“This is yet another significant milestone and meaningful validation of our technology as we continue our TRYbeCA-1 Phase 3 trial evaluating eryaspase in second-line metastatic pancreatic cancer,” said Gil Beyen, CEO of ERYTECH. “We believe that the FDA’s Fast Track designation for eryapase underscores its potential to address this high unmet medical need.”

ERYTECH’s lead product candidate, eryaspase, is being evaluated in a Phase 3 trial (TRYbeCA-1) in secondline metastatic pancreatic cancer in 11 countries in Europe and the United States.

More than 75% of the approximately 500 patients to be enrolled in the trial have been randomized.

An interim superiority analysis, to be conducted by an independent data monitoring committee (IDMC) when two-thirds of the events have occurred, is currently expected to take place around year-end 2020 and the final analysis in the second half of 2021.

In a previous Phase 2b trial, eryaspase demonstrated significant improvement in both overall survival (OS) and progression-free survival (PFS) with a Hazard Ratio (HR) of 0.60 and 0.59 respectively.

Overall, eryaspase was well tolerated and showed a safety profile comparable to that of standard chemotherapy.

Fast Track is a program designed to facilitate the expedited development and review of a new drug, alone or in combination with other drugs, to treat serious or life-threatening conditions for which there is a demonstration of the potential to address an unmet medical need.

The purpose is to advance new drugs earlier for patients who need them.

Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas.

Every year, there are approximately 150,000 new cases of pancreatic cancer diagnosed in Europe and the United States.

Advanced pancreatic cancer is a particularly aggressive cancer, with a five-year survival rate of less than 10%. It is currently the fourth leading cause of cancer death in Europe and the United States and is projected to rise to the second leading cause by 2030.

Limited therapeutic options are currently available for this indication, thereby reinforcing the need to develop new therapeutic strategies and rational drug combinations with the aim of improving overall patient outcomes and quality of life.

TRYbeCA-1 is a randomized, controlled Phase 3 clinical trial evaluating eryaspase in second-line metastatic pancreatic cancer.

The trial is planned to enroll approximately 500 patients at approximately 100 clinical sites in Europe and the United States.

Eligible patients are randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/nab-paclitaxel or an irinotecan-based regimen) or chemotherapy alone.

The primary endpoint of TRYbeCA-1 is overall survival. An interim superiority analysis will be conducted when approximately two-thirds of the events will have occurred.”

https://erytech.com/wp-content/uploads/ERYTECH_PR_FDA_FastTrack_EN_VF-2.pdf

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Use at an Additional Recommended Dose of 400 mg Every Six Weeks for All Approved Adult Indications

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FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Use at an Additional Recommended Dose of 400 mg Every Six Weeks for All Approved Adult Indications

April 28, 2020: “Merck Known as MSD outside the United States and Canada announced that the U.S.FDA has approved an additional recommended dosage of 400 mg every six weeks (Q6W) for KEYTRUDA, Merck’s anti-PD-1 therapy, across all adult indications, including monotherapy and combination therapy.

This indication is approved under accelerated approval based on pharmacokinetic data, the relationship of exposure to efficacy and the relationship of exposure to safety.

Continued approval for this dosing may be contingent upon verification and description of clinical benefit in the confirmatory trials.

This new dosage option will be available in addition to the current dose of 200 mg every three weeks (Q3W).

“The important social distancing measures for COVID-19 have created a number of challenges for people with cancer, including keeping to planned treatment schedules,” said Dr Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

“Today’s approval of an every six-week dosing schedule for KEYTRUDA gives doctors an option to reduce how often patients are at the clinic for their treatment.”

Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT).

Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions.

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see “Selected Important Safety Information” below.

During this unprecedented time, Merck is committed to ensuring our medicines and vaccines reach our patients and customers.

This includes a number of new steps to support patients in the U.S. who may have lost their jobs and insurance coverage.

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells.

KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings.

The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA® (pembrolizumab) Indications

Melanoma: KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer: KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy.

Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer: KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer: KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma: KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma: KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy.

This indication is approved under accelerated approval based on tumor response rate and durability of response.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma: KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) ≥10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High (MSI-H) Cancer: KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

  • solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
  • colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Gastric Cancer: KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer: KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer: KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma: KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
This indication is approved under accelerated approval based on tumor response rate and durability of response.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma: KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma: KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Adult Indications: Additional Dosing Regimen of 400 mg Every 6 Weeks

KEYTRUDA is indicated for use at an additional recommended dosage of 400 mg every 6 weeks for all approved adult indications.”

https://www.mrknewsroom.com/news-release/oncology/fda-approves-mercks-keytruda-pembrolizumab-use-additional-recommended-dose-400

For More News: Merck’s Checkpoint Inhibitor Keytruda (pembrolizumab) Hits Another Mark in Breast Cancer

KEYTRUDA, Merck’s anti-PD-1 therapy Now Approved by the National Medical Products Administration in China for First-Line Treatment of Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) in Combination with Chemotherapy

Merck’s anti-PD-1 therapy KEYTRUDA(pembrolizumab) for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

Chimerix Receives FDA Clearance for Rolling Submission of New Drug Application for Brincidofovir as a Medical Countermeasure for Smallpox

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Chimerix Receives FDA Clearance for Rolling Submission of New Drug Application for Brincidofovir as a Medical Countermeasure for Smallpox

April 28, 2020: “Chimerix, a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases announced that the Company has received clearance from the U.S.FDA for a rolling submission of its NDA for the approval of brincidofovir (BCV) as a medical countermeasure for smallpox.

The Company intends to begin the rolling NDA submission for BCV in May 2020 with completion targeted for mid-2020.

Chimerix is developing BCV as a potential medical countermeasure for smallpox under an ongoing collaboration and funding provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, under ongoing USG Contract No HHSO10201100013C.

“The value of being prepared for viral outbreaks has never been clearer. The potential for engineered or naturally occurring resistance to the currently approved therapy has made the development of BCV imperative,” stated Mike Sherman, Chief Executive Officer of Chimerix.

“The clearance to begin the rolling submission of the NDA for BCV is an important milestone for both the company and BARDA as it brings us one step closer to realizing the mandate of Project Bioshield.

Our NDA preparation is already in process and we look forward to working with BARDA on a potential procurement contract in advance of FDA approval.”

In a lethal model, BCV when administered at varying times post-infection demonstrated a statistically significant survival advantage relative to placebo.
This observation was consistent throughout all time points.”

https://ir.chimerix.com/news-releases/news-release-details/chimerix-receives-fda-clearance-rolling-submission-new-drug

Shionogi Accelerates Development of Potential COVID-19 Treatments and Vaccine

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Shionogi Accelerates Development of Potential COVID-19 Treatments and Vaccine

April 28, 2020: “In response to the novel coronavirus (SARS-CoV-2), Shionogi & Co., Ltd. has joined the ranks of pharmaceutical companies across the globe and is working with public institutions, academia and partner companies in the following efforts to fight against COVID-19:

  1. Commitment to the discovery of novel therapeutic drugs
    Shionogi has initiated a collaborative research effort to identify drugs active against COVID-19 with the Hokkaido University Research Center for Zoonosis Control.

    The research has identified a number of promising lead compounds from internal in vitro studies. As one of the top priorities for Shionogi, the company is accelerating drug discovery efforts with the aim of starting clinical trials later this year.

    Shionogi is committed to the pursuit of effective compounds given the possibility of a long-lasting outbreak and pandemic.
  2. Commitment to prophylactic vaccine development
    UMN Pharma Inc., a group company of Shionogi, is pursuing the discovery and development of a recombinant protein vaccine for COVID-19 utilizing its unique Baculovirus Expression Vector System technology.

    This project began in March 2020 and is supported by the Japan Agency for Medical Research and Development (AMED) [Representative of Research and Development: Dr. Hideki Hasegawa, Director of Influenza Virus Research Center, National Institute of Infectious Diseases].

    Shionogi plans to start clinical trials in Japan within the year.

“Our key focus at Shionogi is to protect people from the threat and consequences of infectious diseases. We are not limiting ourselves to the research and development of therapeutic medications, but are also focused on the total care of infectious disease through awareness building, prevention and diagnosis,” said Akira Kato, Ph.D., president and CEO at Shionogi Inc.

“Shionogi will continue to strive to fulfill its social responsibility and to contribute to recovering the safety and security of society by bringing forward new tools and technologies for the treatment of COVID-19.”

Shionogi’s Commitment to Fighting Infectious Disease
Shionogi has a strong heritage in the field of anti-infectives and has been developing antimicrobial therapies for more than 50 years.

Shionogi is proud to be one of the few large pharmaceutical companies that continues to focus on research and development in anti-infectives.

The company invests the highest proportion of its pharmaceutical revenues in relevant anti-infectives R&D compared to other large pharmaceutical companies.

The company recently launched FETROJA® (cefiderocol) in the U.S. for patients 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections, including pyelonephritis, caused by Gram-negative microorganisms.

Cefiderocol, under the brand name FETCROJA®, is approved by the European Commission for the treatment of infections due to aerobic Gram-negative bacteria in adults 18 years or older with limited treatment options.“

https://www.shionogi.com/shionogi-accelerates-development-of-potential-covid-19-treatments-and-vaccine/

ViiV Healthcare announces £3 million global fund to research the impact of COVID-19 on the HIV community and fill gaps in prevention, treatment and care during the pandemic

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ViiV Healthcare announces £3 million global fund to research the impact of COVID-19 on the HIV community and fill gaps in prevention, treatment and care during the pandemic

April 27, 2020: “ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders announced the creation of the Global HIV and COVID-19 Emergency Response Fund.

The £3 million fund will make available critical financial resources for research projects to study the medical and scientific impact COVID-19 is having on people living with HIV and community-based grants to help address specific challenges to the HIV community created by the global pandemic.

Deborah Waterhouse, CEO at ViiV Healthcare said: “Our mission is to leave no person living with HIV behind and in these unprecedented times, it’s more important than ever that we use our resources and expertise to do just that.

To contribute to finding solutions, ViiV Healthcare is proud to announce the Global HIV and COVID-19 Emergency Fund.

Through this fund, we can support research about the impact of COVID-19 on people living with HIV that is urgently needed.

We will also be able to provide support to local community organisations who are grounded in the response to the pandemic and those who have been impacted by COVID-19 to allow them to continue the important work they are doing to support the HIV community.

We know their support of the broader health system will help save lives.”

The ViiV Healthcare Global HIV and COVID-19 Emergency Response Fund will be divided equally between two programmes and grants will be available through a request for proposal (RFP) process.

The Research Emergency Response Fund will make available up to £1.5 million to support scientific research about the impact of COVID-19 on people living with HIV.

The Community Emergency Response Fund will make available up to £1.5 million to support community-based activities that address the specific challenges faced by people living with HIV during this pandemic. 

Harmony Garges, Chief Medical Officer at ViiV Healthcare said: “Because COVID-19 is caused by a novel virus, we don’t have scientific data to answer some of the important questions that are being raised by people living with HIV and their physicians.

Does HIV put a person at greater risk of getting COVID-19? Are people living with HIV more at risk of severe infection? Is the pandemic preventing people with HIV from seeing their healthcare providers and getting the treatment and care they need?

The HIV community at large has asked us for help to immediately start studying these issues and the Global HIV and COVID-19 Emergency Response Fund has been created to support their efforts.”

About the support programmes
Research Emergency Response Fund
To help improve the understanding and management of the COVID-19 pandemic in people living with HIV, ViiV Healthcare is inviting research proposals within three priority areas of interest that include epidemiology and real-world data, healthcare systems management initiatives in COVID-19 environments, and biomarkers indicative of disease susceptibility, severity, and progression.

Successful proposals will be awarded grants from the £1.5 million Research Emergency Response Fund to undertake independent research through ViiV Healthcare’s existing Investigator Sponsored Studies (ISS) programme.

  Interested applicants may visit covid-19rfp.viivhealthcare.com for proposal materials as well as additional information on eligibility criteria and how to apply. Requests for proposals will be open from 27 April through 18 May.

The proposals will be reviewed by an internal ViiV Healthcare scientific panel and successful applicants notified by 5 June.

Community Emergency Response Fund
ViiV Healthcare will seek applications from community organisations to support their work in addressing the specific challenges that have arisen for people living with HIV or affected by HIV as a result of the COVID-19 pandemic.

Through the £1.5 million Community Emergency Response Fund, grants will be made available to support ongoing access to critical HIV prevention, care and outreach services, differentiated models of service delivery, short term payments for critical community staff, and community monitoring and feedback on the impact of COVID-19 to HIV services and support.

The Community Emergency Fund is not intended for the purchase of pharmaceutical products.

The Community Emergency Response Fund will support existing grantees of ViiV Healthcare’s Positive Action or Government Affairs (GA) or Global Public Health (GPH). Positive Action US Grantees and select COVIDRESPONSE

Requests for proposals will be open from 27 April through 15 May. The proposals will be reviewed by an internal ViiV Healthcare panel and successful applicants notified by 25 May.

Our actions to support the broader global response
We are also proud of everything our majority shareholder, GSK, is doing to contribute to solutions to the COVID-19 pandemic.

This includes the research and production of candidate COVID-19 vaccines and the groundbreaking collaboration recently announced between GSK and Sanofi, bringing together two of the world’s largest vaccine companies to fight COVID-19.

Along with GSK, we are also involved in a number of partnerships and initiatives to respond to COVID-19 and are working together to conduct screening and research into new medicines as well as helping frontline health workers and offering expertise where we can.”

https://viivhealthcare.com/en-gb/media/press-releases/2020/april/viiv-healthcare-announces-p3-million-global-fund-to-research-the/

Can an existing HIV medication slow the spread of COVID-19?

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Can an existing HIV medication slow the spread of COVID-19?

April 28, 2020: A team of scientists from St. Michael’s Hospital, Sinai Health and Sunnybrook Health Sciences Centre have launched a clinical trial to understand whether an existing drug used for HIV treatment and prevention may work to prevent COVID-19 infection.

The trial will examine whether post-exposure prophylaxis (PEP), which is a medication a person takes once they’ve been exposed to a virus to prevent infection, could halt or slow the spread of COVID-19 in groups of people who have been exposed to a confirmed case.

The drug in question – Kaletra (lopinavir/ritonavir as PEP)- has long been used in this capacity to prevent HIV in those who have been exposed to the virus.

“Early studies of the use of this medication as post-exposure prophylaxis therapy in other coronaviruses such as SARS and MERS have been promising,” says Dr Darrell Tan, the study’s lead investigator who is also a scientist at the MAP Centre for Urban Health Solutions and an infectious disease physician at St. Michael’s.

“These are so-called ‘cousin’ viruses to COVID-19 and we want to understand whether lopinavir/ritonavir as PEP could impact its spread as well.”

Dr Tan, along with his co-leads Dr Allison McGeer, a senior clinician-scientist at the Lunenfeld-Tanenbaum Research Institute of Sinai Health, and Dr Adrienne Chan, a clinician-investigator at the Sunnybrook Research Institute, will collaborate with Toronto Public Health to identify confirmed cases of COVID-19.

They’ll then connect with those exposed to confirmed cases to enroll them in the study.

“A great many people from all across Toronto have worked together to get this study started,” says Dr McGeer. “We know we need to be finding solutions that contribute to stopping the spread of this disease as quickly as possible.”

The group of contacts of one patient with confirmed COVID-19 will be identified as a ‘cluster.’ Entire clusters will be randomized to receive either the medication or no intervention.

The team of researchers will then track whether or not participants develop COVID-19 by asking them to complete self-tests for the virus weekly. To limit contact, the research team will rely on courier and virtual or phone meetings with participants.

This type of study is called a ring trial design and was an effective method of using vaccines to eradicate smallpox and test treatments for Ebola.

“Kaletra is a drug that the HIV community has been using globally for two decades, and has also been commonly used at scale in low-resource settings.

This means it could be easily scaleable not just in Canada, but internationally if we are able to demonstrate its effectiveness in the prevention of COVID-19,” says Dr Chan, who is also an infectious disease physician at Sunnybrook Health Sciences Centre.

Participants randomized to receive the study drug will take it for 14 days, as this is the current estimated incubation period for COVID-19.

“If this strategy works, it could be a major turning point in our global effort to stop a virus where, as we have seen, the outcomes can be devastating,” says Dr Tan.

“We are hopeful that our work will bring us closer to understanding how to slow or contain the spread of COVID-19.”

https://eurekalert.org/pub_releases/2020-04/smh-cae042720.php

Novartis announces plan to initiate clinical trial of canakinumab for patients with COVID-19 pneumonia

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Novartis announces plan to initiate clinical trial of canakinumab for patients with COVID-19 pneumonia

April 28, 2020: “Novartis announced plans to initiate a Phase III clinical trial to study canakinumab in patients with COVID-19 pneumonia.

The CAN-COVID trial will examine the efficacy of utilizing canakinumab, an interleukin (IL)-1β blocker, to treat a type of severe immune overreaction called cytokine release syndrome (CRS) in people with COVID-19 pneumonia.

CRS could lead to life-threatening complications in patients with COVID-19.

The study builds on early evidence from lab tests of COVID-19 patients who showed elevated IL-1β levels, among other cytokines.

Novartis aims to rapidly enroll 450 patients at multiple medical centers across France, Germany, Italy, Spain, UK and the US and randomize them to receive either canakinumab or placebo on top of standard of care (SoC).

The primary objective of the study is to demonstrate the benefit of canakinumab in combination with SoC in increasing the chance of survival without the need for invasive mechanical ventilation among patients with COVID-19 pneumonia.

Top-line results are anticipated in late summer 2020.

This trial initiation is part of the overall Novartis approach to applying our best science to tackling the issues related to COVID-19 and further underscores Novartis commitment to quickly deploy R&D resources, medicines, clinical expertise and philanthropic aid to combat COVID-19.”

https://www.novartis.com/news/novartis-announces-plan-initiate-clinical-trial-canakinumab-patients-covid-19-pneumonia

Neurocrine Biosciences Announces FDA Approval of Once-Daily ONGENTYS® (opicapone) as an Add-On Treatment for Patients with Parkinson’s Disease Experiencing “Off” Episodes

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Neurocrine Biosciences Announces FDA Approval of Once-Daily ONGENTYS® (opicapone) as an Add-On Treatment for Patients with Parkinson’s Disease Experiencing “Off” Episodes

April 27, 2020: “Neurocrine Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral ONGENTYS® (opicapone) 25 mg and 50 mg capsules as an add-on treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes.

As the disease progresses, patients taking levodopa/carbidopa may begin to experience “off” time between treatment doses, during which an increase in Parkinson’s disease motor symptoms such as tremor, slowed movement and difficulty walking occur.

ONGENTYS also increases “on” time without troublesome dyskinesia, the time when the motor symptoms of a patient with Parkinson’s disease are better controlled. The company plans to launch ONGENTYS later this year.

“The FDA approval of ONGENTYS represents an important new treatment option for people with Parkinson’s disease,” said Robert A. Hauser, M.D., Professor of Neurology and Director, University of South Florida Parkinson’s Disease and Movement Disorders Center.

“As Parkinson’s disease progresses, first-line treatments such as levodopa begin to lose effectiveness and the beneficial effects of levodopa begin to wear off more quickly, causing more frequent and often debilitating motor fluctuations in patients.

Clinical studies have shown that adding once-daily ONGENTYS to levodopa therapy significantly reduced “off” time, leading to better and more consistent motor symptom control.”

Parkinson’s disease is the second most common neurodegenerative disorder in the United States after Alzheimer’s disease.

 About one million Americans have Parkinson’s disease and each year, an estimated 50,000 people in the United States are newly diagnosed with this chronic, progressive and debilitating neurodegenerative disorder.

“The FDA approval of ONGENTYS provides patients living with Parkinson’s disease with an important new treatment option to help manage the disruptive and unpredictable motor fluctuations by decreasing “off” episodes and increasing “on” time without troublesome dyskinesia when taking levodopa/carbidopa,” said Kevin C. Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences.

“At Neurocrine Biosciences, our mission is to relieve patient suffering and we look forward to working with the Parkinson’s disease community to make this new therapy available to patients later this year.” 

ONGENTYS is an oral, selective catechol-O-methyltransferase (COMT) inhibitor that helps block the COMT enzyme which breaks down levodopa, the gold standard therapy for controlling motor symptoms in patients with Parkinson’s disease.

ONGENTYS protects levodopa by reducing its breakdown in the blood, making more levodopa available to reach the brain, prolonging its clinical effects and helping patients achieve motor symptom control.

“Due to the progressive nature of Parkinson’s disease, those living with the condition often struggle to control their motor fluctuations, affecting a wide range of functions, including speech, balance and movement, which adversely impact many aspects of life,” said John L. Lehr, President and Chief Executive Officer of the Parkinson’s Foundation.

“The Parkinson’s disease community is encouraged by the FDA approval of a new add-on treatment option to help patients further control symptoms, enabling them to better cope with this progressive disease.”

The FDA approval of ONGENTYS is supported by data from 38 clinical studies, including two multinational Phase III clinical studies (BIPARK-1 and BIPARK-2), with more than 1,000 Parkinson’s disease patients treated with ONGENTYS.

In the BIPARK-1 trial, approximately 600 patients with Parkinson’s disease and motor fluctuations received one of three doses of ONGENTYS (5 mg, 25 mg or 50 mg), placebo or 200 mg doses of the COMT inhibitor entacapone for 14 or 15 weeks.

In the BIPARK-2 trial, approximately 400 patients received one of two doses of ONGENTYS (25 mg or 50 mg) or placebo for 14 or 15 weeks. Both studies included a one-year open-label extension.

Data from both trials showed that ONGENTYS 50 mg significantly reduced “off” time from baseline to week 14 or 15 compared to placebo. “On” time without troublesome dyskinesia also increased from baseline to week 14 or 15 compared to placebo.

Pooled safety data from the BIPARK-1 and BIPARK-2 studies indicated that the most common adverse reactions across all patients treated with ONGENTYS (incidence at least 4% and greater than placebo) were dyskinesia, constipation, blood creatine kinase increase, hypotension/syncope, and weight decrease.

In June 2016, BIAL – Portela & CA, S.A. (BIAL) received approval from the European Commission for ONGENTYS as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations.

BIAL currently markets ONGENTYS in Germany, United Kingdom, Spain, Portugal and Italy. Neurocrine Biosciences in-licensed opicapone from BIAL in 2017 and has exclusive development and commercialization rights in the U.S. and Canada.

ONGENTYS® (opicapone) Capsules:  ONGENTYS is a novel, once-daily, oral, peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor approved by the U.S.FDA as an add-on treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes.

ONGENTYS inhibits the COMT enzyme, which breaks down levodopa, making more levodopa available to reach the brain.

Important Safety Information
Contraindications
ONGENTYS is contraindicated in patients with:

  • Concomitant use of non-selective monoamine oxidase (MAO) inhibitors.
  • Pheochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.”

https://neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-announces-fda-approval-once-daily-0  

Sanofi and Regeneron provide an update on U.S. Phase 2/3 adaptive-designed trial of Kevzara® (sarilumab) in hospitalized COVID-19 patients

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Sanofi and Regeneron provide an update on U.S. Phase 2/3 adaptive-designed trial of Kevzara® (sarilumab) in hospitalized COVID-19 patients

April 27, 2020:” Sanofi and Regeneron Pharmaceuticals, Inc. announced the preliminary results from the Phase 2 portion of an ongoing Phase 2/3 trial evaluating Kevzara® (sarilumab), an interleukin-6 (IL-6) receptor antibody, in hospitalized patients with “severe” or “critical” respiratory illness caused by COVID-19.

Following a review by the Independent Data Monitoring Committee (IDMC) of all available Phase 2 and Phase 3 data, the trial will be immediately amended so that only “critical” patients continue to be enrolled to receive Kevzara 400 mg or placebo.  

The randomized Phase 2 portion of the trial compared intravenously-administered Kevzara higher dose (400 mg), Kevzara lower dose (200 mg) and placebo.

It assessed 457 hospitalized patients, who were categorized at baseline as having either “severe” illness (28% of patients), “critical” illness (49% of patients) or “multi-system organ dysfunction” (MSOD) (23% of patients).

Patients were classified as “severe” if they required oxygen supplementation without mechanical or high-flow oxygenation; or “critical” if they required mechanical ventilation or high-flow oxygenation or required treatment in an intensive care unit.

Preliminary analysis of the Phase 2 portion of the trial demonstrated that Kevzara rapidly lowered C-reactive protein, a key marker of inflammation, meeting the primary endpoint (see table below).

Baseline levels of IL-6 were elevated across all treatment arms, with higher levels observed in “critical” patients compared to “severe” patients. Additionally, no new safety findings were observed with the use of Kevzara in COVID-19 patients.

Analysis of clinical outcomes in the Phase 2 trial was exploratory and pre-specified to focus on the “severe” and “critical” groups. In the preliminary Phase 2 analysis, Kevzara had no notable benefit on clinical outcomes when combining the “severe” and “critical” groups, versus placebo.

However, there were negative trends for most outcomes in the “severe” group, while there were positive trends for all outcomes in the “critical” group (see table below).

Subsequent to the IDMC review, Regeneron and Sanofi conducted a review of the discontinued “severe” group that revealed the negative trends in Phase 2 (n=126) were not reproduced in Phase 3 (n=276), and that clinical outcomes were balanced across all treatment arms.

Outcomes for the “severe” group were better than expected based on prior reports, regardless of treatment assignment: for example, in the Phase 2 portion, approximately 80% were discharged, 10% of patients died and 10% remain hospitalized.

“Even in a pandemic setting, it’s both crucial and possible to obtain controlled data in adequately-sized trials to provide the evidence needed to inform optimal medical care,” said George D. Yancopoulos, M.D., Ph.D., Regeneron Co-Founder, President and Chief Scientific Officer.

 “Emerging evidence with Kevzara and other repurposed drugs in the COVID-19 crisis highlight the challenges of making decisions about existing medicines for new viral threats using small, uncontrolled studies.

We await results of the ongoing Phase 3 trial to learn more about COVID-19, and better understand whether some patients may benefit from Kevzara treatment.

In addition, there is an acute need for tailored approaches that specifically target this virus. To that end, Regeneron is rapidly advancing our targeted anti-SARS-CoV-2 antibody cocktail and we plan to initiate clinical trials in June.”

The Kevzara trial was designed after a small (n=21), single-arm study in China among mostly severe, febrile hospitalized COVID-19 patients, which found elevated IL-6 levels, and suggested that inhibiting this pathway with the IL-6 inhibitor tocilizumab rapidly reduced fever and improved oxygenation in severe patients, allowing for successful hospital discharge.

These uncontrolled findings require confirmation in adequately-sized and well-controlled trials.  

Last month, Regeneron and Sanofi moved rapidly to evaluate Kevzara in a prospective, randomized, placebo-controlled adaptively-designed U.S. Phase 2/3 trial in collaboration with U.S. groups including the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, the Food and Drug Administration (FDA), and hospitals across the country.

“At Sanofi, we are committed to helping combat the global COVID-19 pandemic.  As we quickly follow the science to better understand this disease and explore how best to treat patients, these initial results from the randomized clinical trial setting provide physicians much-needed insights and information regarding Kevzara for patients with COVID-19,”  said John Reed, M.D., Ph.D., Sanofi’s Global Head of Research and Development. 

“While our evaluation of the use of Kevzara for COVID-19 treatment remains an investigational approach, Sanofi continues to stay at the forefront of multiple initiatives to fight this disease, including researching other potential treatment options, developing vaccine candidates that can be manufactured at large-scale, and potential collaboration for an innovative SARS-CoV-2 smartphone-based self-testing solution.”

The Phase 2 numerical results are presented in the table, including exploratory clinical endpoints for the “critical” group, which is the focus of the ongoing Phase 3 trial.

The ongoing portion of the Phase 3 trial, which is continuing to enroll, currently includes more than 600 patients in the “critical” group.  Regeneron and Sanofi remain blinded to the ongoing portion of the Phase 3 trial and expect to report results by June.

In addition, the companies are also conducting a second trial in countries outside of the U.S. The Phase 3 trial of Kevzara in approximately 400 patients hospitalized with COVID-19 infection is currently enrolling in Italy, Spain, Germany, France, Canada, Russia, Israel and Japan. Initial results from this second trial are expected in the third quarter. The findings from the U.S. trial will be shared immediately with the IDMC and similar amendments to the trial outside the U.S. will be considered.

The U.S. Kevzara trial has been funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; and BARDA, under OT number: HHSO100201700020C.

The use of Kevzara to treat the symptoms of COVID-19 is investigational and has not been fully evaluated by any regulatory authority.”

https://www.sanofi.com/en/media-room/press-releases/2020/2020-04-27-12-58-00

For more News: Sanofi: First patient outside U.S. treated in global Kevzara® (sarilumab) clinical trial program for patients with severe COVID-19

Sanofi: Phase 3 trial of Libtayo® (cemiplimab) as monotherapy for first-line advanced non-small cell lung cancer stopped early due to highly significant improvement in overall survival

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Sanofi: Phase 3 trial of Libtayo® (cemiplimab) as monotherapy for first-line advanced non-small cell lung cancer stopped early due to highly significant improvement in overall survival

April 27, 2020: “Sanofi and Regeneron Pharmaceuticals, Inc. announced the primary endpoint of overall survival (OS) was met in a Phase 3 trial comparing the PD-1 inhibitor Libtayo® (cemiplimab) to platinum doublet chemotherapy in patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) that tested positive for PD-L1 in ≥50% of tumor cells.

Based on a recommendation by the independent Data Monitoring Committee to stop the trial early, the trial will be modified to allow all patients to receive Libtayo for this investigational use.

The data will form the basis of regulatory submissions in the U.S. and European Union (EU) in 2020.

“While demonstrating a survival benefit in first-line NSCLC has been challenging for immunotherapies, the one FDA-approved anti-PD-1 monotherapy has changed the therapeutic paradigm,” said George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer of Regeneron. “

We are pleased with the results of this trial that demonstrate the survival benefit of Libtayo in these patients and hope it may become a potential alternative for physicians and patients.”

A protocol-specified interim analysis conducted by the Independent Data Monitoring Committee demonstrated that patients treated with Libtayo monotherapy had a significant increase in OS.

Libtayo decreased the risk of death by 32.4% (HR=0.676; CI:0.525-0.870, p=0.002), compared to platinum doublet chemotherapy, despite a third of patients entering the trial within the past six months and all chemotherapy patients being able to crossover to Libtayo if their disease progressed.

No new Libtayo safety signal was identified. Detailed trial data will be presented at a future medical meeting.

“This is the largest clinical trial evaluating a PD-1 inhibitor as first-line monotherapy in patients with advanced non-small cell lung cancer with high PD-L1 expression.

The positive results are extremely encouraging, and we look forward to advancing a potential new treatment option for these patients,” said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. “We are grateful to all of the investigators and patients who participated in the global trial.”

Lung cancer is the leading cause of cancer death worldwide. In 2020, more than 2.2 million new cases are expected to be diagnosed globally, with 228,800 new cases in the U.S. alone.

Approximately 85% of all lung cancers are NSCLC, with an estimated 25% to 30% of cases expected to test positive for PD-L1 in ≥50% of tumor cells.

While immunotherapies have transformed advanced NSCLC treatment in recent years, there remains an unmet need to optimize the identification and treatment of patients with high PD-L1 expression.

Libtayo is being jointly developed and commercialized by Regeneron and Sanofi under a global collaboration agreement.

The use of Libtayo to treat advanced NSCLC is investigational and has not been fully evaluated by any regulatory authority.

Phase 3 Trial: The open-label, randomized, multi-center Phase 3 trial investigated the first-line treatment of Libtayo monotherapy compared to platinum doublet chemotherapy in squamous or non-squamous advanced NSCLC that tested positive for PD-L1 in ≥50% of tumor cells.

The trial included 712 patients (of whom 710 were included in the interim analysis) with locally advanced NSCLC (Stage IIIB/C), who were not candidates for surgical resection or definitive chemoradiation or had progressed after treatment with definitive chemoradiation, or previously untreated metastatic NSCLC (Stage IV).

The trial offers the largest data set from a pivotal trial currently available for this patient population.

Patients were randomized 1:1 to receive either Libtayo 350 mg administered intravenously every three weeks for up to 108 weeks or an investigator-selected, standard-of-care, platinum-based, doublet chemotherapy regimen for four to six cycles (with or without maintenance pemetrexed chemotherapy).

The co-primary endpoints are OS and progression-free survival (PFS), and secondary endpoints include overall response rate, duration of response and quality of life.

The trial was designed to reflect current and emerging treatment paradigms. Inclusion criteria allowed patients with NSCLC that had: controlled hepatitis B, hepatitis C or HIV; pre-treated and stable brain metastases; and/or locally advanced disease that had progressed on definitive chemoradiation.

Patients whose disease progressed in the trial were able to change their therapy: those in the chemotherapy arm were allowed to crossover into the Libtayo arm, while those in the Libtayo arm were allowed to combine Libtayo treatment with four to six cycles of chemotherapy.

A separate Phase 3 trial evaluating the first-line combination of Libtayo and chemotherapy in patients with advanced NSCLC irrespective of PD-L1 expression is also underway and expected to be fully enrolled in 2020.


Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.

Libtayo is approved in the U.S., European Union, and other countries for adults with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

In the U.S., the generic name for Libtayo in its approved indication is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. In skin cancer, this includes a potentially registrational Phase 2 trial in basal cell carcinoma and additional trials in adjuvant and neoadjuvant CSCC.

Libtayo is also being investigated in a potentially registrational Phase 3 trial in cervical cancer, as well as in trials combining Libtayo with novel therapeutic approaches for both solid tumors and blood cancers.

These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.”

https://www.sanofi.com/en/media-room/press-releases/2020/2020-04-27-13-00-00

Coronavirus (COVID-19) Update: FDA Continues to Ensure Availability of Alcohol-Based Hand Sanitizer During the COVID-19 Pandemic, Addresses Safety Concerns

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Coronavirus (COVID-19) Update: FDA Continues to Ensure Availability of Alcohol-Based Hand Sanitizer During the COVID-19 Pandemic, Addresses Safety Concerns

April 27, 2020: “The U.S. Food and Drug Administration provided an update on its efforts to ensure the availability of alcohol-based sanitizer to help meet the demand for hand sanitizer during the COVID-19 pandemic.

As a result of the agency’s significant flexibility, more than 1,500 additional manufacturers have registered with the agency to produce hand sanitizer.

At the same time, the agency is addressing safety concerns related to products being sold that are not in line with the FDA’s policy and others being marketed with unproven claims.

“We appreciate industry’s willingness to help supply alcohol-based hand sanitizer to the market to meet the increasing demand for these products and are grateful for their efforts,” said FDA Commissioner Stephen M. Hahn, M.D.

“With this increased supply comes our continued mission to ensure safety of these products. It is important that hand sanitizer is manufactured in a way that makes them unpalatable to people, especially young children, and that they are appropriately labelled to discourage accidental or intentional ingestion.

Additionally, hand sanitizers are not proven to treat COVID-19, and like other products meant for external use, are not for ingestion, inhalation, or intravenous use.”

Following the FDA’s guidance aimed at increasing availability of alcohol-based hand sanitizers, the agency has received feedback and questions over the past few weeks from industry and congressional members, particularly regarding the need to use denatured alcohol for these products.

Adding these denaturants to the alcohol renders the product more bitter and less appealing to ingest, particularly for young children.

While the agency understands the economic and business reasons behind foregoing this step in the manufacturing process, such an approach undermines the agency’s mission of helping to ensure the safety of FDA-regulated products for consumer use, which is the FDA’s top priority.

This approach is consistent with the FDA’s policies prior to the COVID-19 pandemic on including denatured alcohol in hand sanitizer and is even more important now as more consumers rely on its use as a mitigation tool against the deadly virus.

To illustrate the importance of using denatured alcohol and, according to an FDA analysis of data provided by the U.S. Centers for Disease Control and Prevention and the American Association of Poison Control Centers surveillance team, calls to the National Poison Data System last month related to hand sanitizer increased by 79% compared to March 2019.

The majority of these calls were for unintentional exposures in children 5 years of age and younger. Every year, there are hundreds of calls to poison control centers regarding exposure to hand sanitizer, many of which result in adverse events, including death.

Unfortunately, ingestion of only a small amount of hand sanitizer may be potentially lethal in a young child.

This month, the agency received an adverse event report of a 13-year-old child drinking hand sanitizer packaged in a liquor bottle from a distiller.

The sanitizer was not denatured and was reported to taste like normal drinking alcohol. To protect consumers, especially children, it is important to make hand sanitizer unpalatable.

The FDA also found that the product ingested by the 13-year-old child was not consistent with the labelling component of the agency’s temporary policy— underscoring the importance that these products include a Drug Facts Label, warnings to keep the product out of reach of children, information to get medical help or call a poison control center right away if swallowed and to supervise use in children under 6 years of age to prevent accidental swallowing.

These safety measures apply regardless of where the product is intended to be used, as it can easily be distributed beyond the original intended setting.

The FDA is also concerned about hand sanitizer products being sold by some manufacturers during the COVID-19 pandemic with unproven claims.

Last week, the agency issued its first warning letter for a hand sanitizer product marketed with unproven COVID-19-related claims, in violation of federal law.

The letter was issued to Prefense LLC for selling their product with misleading claims, for example, “Prefense…protects you from germs with just one application per day! It’s like wearing an invisible glove.” The company’s webpage also states that Prefense can, “protect you from pathogens up to 24 hours or for 10 hand washes.”

The FDA is not aware of any evidence that hand sanitizer products can protect consumers for 24 hours or after multiple hand-washings.

These types of claims may put consumers at risk by leading to a false sense of security and resulting in infrequent hand washing or hand sanitizing. The agency urges consumers to be vigilant of products sold with misleading, unproven claims, by following our updates on our website.

The FDA remains committed to working with manufacturers, compounders, state boards of pharmacy and the public to increase the safe supply of alcohol-based hand sanitizer available to Americans, as well as continuing to take appropriate action against manufacturers making unproven claims.

Consumers, manufacturers or distributors who have questions for the FDA regarding hand sanitizers should email [email protected].

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-ensure-availability-alcohol-based-hand-sanitizer-during

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