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FDA’s ok for Chembio Zika blood test

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FDA’s ok for Chembio Zika blood test

June 08, 2020 “Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostic company focused on infectious diseases, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the DPP Zika IgM System.

The Chembio DPP Zika IgM System is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human serum, potassium-EDTA plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens, collected from individuals meeting the CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated).

Additionally, this clearance represents the initial U.S. regulatory approval for the DPP Micro Reader. The DPP Micro Reader is a handheld portable analyzer that produces numerical results from Chembio DPP tests and is compatible with the entire portfolio of Chembio DPP tests.

The DPP Zika System, which includes the DPP Zika IgM Assay and DPP Micro Reader, detects IgM antibodies from a 10uL fingerstick blood sample and provides numerical results after 15 minutes of sample incubation and 15 seconds of test read time.

“Our DPP Zika System offers superior accuracy, rapid detection and the ease of use Chembio’s DPP point-of-care technology is known for. We are thankful for the support of BARDA in this development program and for their recognition of the value of our technology,” stated Rick Eberly, Chembio’s President and Chief Executive Officer.

“FDA clearance for our DPP Zika System represents two significant execution milestones, the initial clearance for our DPP Micro Reader in the U.S. and expansion of our testing menu. We appreciate the critical support and guidance provided by the FDA first through Emergency Use Authorization and then through 510(k) clearance which allowed us to deliver tests to the market quickly and continuously during a time of need.”

Funds used to develop the system included $5.9 million awarded in a previously announced contract with 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 (HHS).

About Chembio Diagnostics
Chembio is a leading point-of-care diagnostics company focused on detecting and diagnosing infectious diseases, including COVID-19, sexually transmitted disease, and fever and tropical disease. The company’s patented DPP technology platform, which uses a small drop of blood from the fingertip, provides high-quality, cost-effective results in approximately 15 minutes. Coupled with Chembio’s extensive scientific expertise, its novel DPP technology offers broad market applications beyond infectious disease. Chembio’s products are sold globally, directly and through distributors, to hospitals and clinics, physician offices, clinical laboratories, public health organizations, government agencies, and consumers. Learn more at www.chembio.com.

Press Releases

AstraZeneca Reportedly Approaches Gilead for Potential Merger

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AstraZeneca Reportedly Approaches Gilead for Potential Merger

JUN 8, 2020 AstraZeneca AZN approached Gilead Sciences GILD last month for a potential merger deal, Bloomberg reported on Sunday, citing people familiar with the matter.

The report mentioned that no terms of the transaction were specified and the companies aren’t in formal talk, the people said.

If the two companies were to combine into one, it would be the biggest health-care deal ever, surpassing Bristol-Myers’ BMY $74 billion purchase of Celgene last year. The combined companies have a market cap of $236 billion as of Friday’s close.

The report also said that Gilead is presently not showing any interest in merging with any other large pharma company.

Related:
https://lifepronow.com/blog/2020/05/02/gileads-investigational-antiviral-remdesivir-receives-u-s-food-and-drug-administration-emergency-use-authorization-for-the-treatment-of-covid-19/

Gilead Announces Approval of Veklury® (remdesivir) in Japan


It seems AstraZeneca’s interest in Gilead is due to the latter’s investigational antiviral remdesivir, which is being developed in late-stage studies to treat COVID-19.

Also, the FDA has granted emergency-use authorization to Remdesivir to treat the disease. Remdesivir was previously under testing for Ebola virus.


Source: https://www.nasdaq.com/articles/astrazeneca-reportedly-approaches-gilead-for-potential-merger-2020-06-08

OX2 Therapeutics receives FDA approval for a Phase I Clinical trial to treat High Grade Glioblastoma

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OX2 Therapeutics receives FDA approval for a Phase I Clinical trial to treat High Grade Glioblastoma

June 08, 2020, OX2 Therapeutics, Inc, a privately held Minneapolis company, announced that “”it has received clearance from the U.S. Food and Drug Administration to launch a phase 1 clinical trial with its new combination therapy for treatment of recurrent high grade brain tumors for which no curative therapy is available.

OX2 Therapeutics developed the first of its kind peptide platform that targets the activation receptor of the CD200 immune checkpoint. The peptide activates the immune system through a mechanism that modulates the suppressive effects of the CD200, PD-1/PD-L1 and CTLA4 immune checkpoints to allow a more robust anti-tumor response. “This single peptide has the potential to replace the toxic antibody therapies that are currently used to block these immune checkpoints,” said Drs. Moertel and Olin. OX2 Therapeutics intends to initiate a phase I single center, open-label, dose-escalation clinical trial in adult patients with recurrent glioblastoma.

This will be followed by a pediatric trial for children with recurrent malignant brain tumors based on its safety and pharmacokinetic profile. “The FDA approval of our IND application to proceed to human trials is another important milestone for OX2 Therapeutics and the Brain Tumor Program at the Masonic Cancer Center, University of Minnesota,” stated Michael Olin, PhD. “We are looking forward to evaluating the safety of our peptide (CD200AR-L) combined with our brain tumor initiating cell tumor lysate (GBM6-AD).”

In addition, he states, although this new breakthrough therapy is currently being evaluated on CNS tumors, the number one cause of cancer-related mortality in children, this first of its kind peptide is being developed as a platform to be translatable to the treatment of other solid tumors.

About OX2 Therapeutics, Inc.
OX2 Therapeutics is a clinical stage, biopharmaceutical company developing new therapies to turn cancers into manageable and potentially curable diseases. OX2 Therapeutics was founded in 2016 by Dr. Michael Olin, PhD, Associate Professor, Christopher Moertel, MD, Professor, both from the Division of Hematology/Oncology, Department of Pediatrics, in the University of Minnesota School of Medicine and Sumant Dhawan, VP Operations. Shortly after the formation of the company Jeff Liter joined the team as CEO/CFO.The scientific advisory committee includes G. Elizabeth Pluhar, D.V.M., PhD, Thomas Molitor, PhD and Yuk Sham, PhD. “The FDA filing and IND approval of the OX2 combination of CD200AR-L and GBM6-AD was successfully filed with the qualified help of our regulatory consultant, Frestedt, Inc.,” noted Dr. Moertel.”

Source of news: https://www.einpresswire.com/article/518864502/ox2-therapeutics-receives-fda-approval-for-a-phase-i-clinical-trial-to-treat-high-grade-glioblastoma

FDA Publicly Shares Antibody Test Performance Data From Kits as Part of Validation Study

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FDA Publicly Shares Antibody Test Performance Data From Kits as Part of Validation Study
June 04, 2020: “U.S. Food and Drug Administration publicly posted test performance data from four more antibody, or serology, test kits on open.fda.gov from its independent performance validation study effort with the National Institutes of Health’s (NIH) National Cancer Institute (NCI).

These results are among the first to come from a collaborative effort by the FDA, NIH, Centers for Disease Control and Prevention (CDC) and Biomedical Advanced Research and Development Authority (BARDA).

Additional performance data will be made available as the FDA reviews and determines if any further actions are appropriate for those test kits prior to publication.

An intergovernmental team is leveraging NCI’s capability for the U.S. Government to independently evaluate certain antibody tests, including antibody tests that were not the subject of a EUA or pre-EUA, as well as those that were under FDA review. Data from an antibody test kit were first posted on May 4, 2020.

Today, the FDA has shared data from four additional tests.

“These data are the result of an important cross-government effort,” said FDA Commissioner Stephen M. Hahn, M.D. “There’s been incredible teamwork across scientists at the FDA, NCI, CDC and BARDA and I’m glad to be sharing the data with the wider research community.

By posting these data publicly, we’re advancing not only Americans’ access to trustworthy tests, but also the wider field of research into serology testing.”

“We’re pleased to step up and provide NCI’s laboratory capacity and expertise to support this crucial partnership to further our understanding of antibody test performances,” said NCI Director Norman E. “Ned” Sharpless, M.D.

“This speaks to the terrific convening power of the federal government and highlights the strength of cross-agency collaboration within the Department of Health and Human Services.

NCI will continue to play its part by examining these kits and generating important data that supports the FDA’s decision-making.”

The testing was performed at the Frederick National Laboratory for Cancer Research, a Federally Funded Research and Development Center sponsored by NCI and through a collaborative effort with the FDA, NIH, CDC and BARDA to evaluate certain serological tests.

Essential reference samples and materials used in the evaluation were provided by the NIH National Institute of Allergy and Infectious Diseases, the Mount Sinai Health System, the Icahn School of Medicine at Mount Sinai, including members of the Departments of Microbiology and Pathology, and the Vitalant Research Institute.

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-publicly-shares-antibody-test-performance-data-kits-part-validation

FDA Approves Antibiotic to Treat Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia

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FDA Approves Antibiotic to Treat Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia
June 04, 2020: “U.S. Food and Drug Administration approved Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years of age and older.

Recarbrio was previously FDA-approved to treat patients with complicated urinary tract infections and complicated intra-abdominal infections who have limited or no alternative treatment options.

Approval of this indication is based on limited clinical safety and efficacy data for Recarbrio.

“As a public health agency, the FDA addresses the threat of antimicrobial-resistant infections by facilitating the development of safe and effective new treatments,” said Sumathi Nambiar, M.D., M.P.H., director of the Division of Anti-Infectives within the Office of Infectious Disease in FDA’s Center for Drug Evaluation and Research.

“These efforts provide more options to fight serious bacterial infections and get new, safe and effective therapies to patients as soon as possible.”

HABP and VABP are a type of pneumonia that occurs in hospitalized patients and can cause symptoms such as fever, chills, cough, chest pain and increased oxygen requirements.

Recarbrio is a combination of imipenem-cilastatin and relebactam. The drug is administered intravenously by a health care professional.

The safety and efficacy of Recarbrio for the treatment of HABP/VABP were evaluated in a randomized, controlled clinical trial of 535 hospitalized adults with HABP/VABP due gram-negative bacteria (a type of bacteria) in which 266 patients were treated with Recarbrio and 269 patients were treated with piperacillin-tazobactam, another antibacterial drug.

Overall, 16% of patients who received Recarbrio and 21% of patients who received piperacillin-tazobactam died through Day 28 of the study.

The most common adverse reactions observed in patients treated with Recarbrio for HABP/VABP included increased aspartate/alanine aminotransferases (increased liver enzymes), anemia, diarrhea, hypokalemia (low potassium) and hyponatremia (low sodium).

Before initiating therapy with Recarbrio, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams and other allergens. Recarbrio should not be used in patients who are prone to seizures and other central nervous system disorders. 

Clostridioides difficile-associated diarrhea has been reported with use of nearly all antibacterial agents, including Recarbrio, and may range in severity from mild diarrhea to fatal colitis.

This application was granted a Qualified Infectious Disease Program (QIDP) designation.

This designation is given to antibacterial and antifungal drug products intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act.

Additionally, as part of QIDP designation, the FDA granted this application Fast Track and Priority Review designations.

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/fda-approves-antibiotic-treat-hospital-acquired-bacterial-pneumonia-and-ventilator-associated

Coronavirus (COVID-19) Update: Daily Roundup June 4, 2020

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Coronavirus (COVID-19) Update: Daily Roundup June 4, 2020
June 04, 2020: “The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
  • Today, the FDA issued a new video external Link Disclaimer resource explaining the different categories of tests in the fight against COVID-19: diagnostic tests and antibody tests.

    As the video explains, diagnostic tests can tell if the tested person currently is infected. Antibody or serology tests detect if the person’s blood contains antibodies to coronavirus.

    The body produces antibodies when one becomes infected by the virus, and they help the immune system fight off the infection.

    If an antibody test finds antibodies in the blood, it likely means the person has been previously infected with the virus.

    Antibody tests do not detect whether a person is currently infected and should not be used to diagnose a current COVID-19 infection.

    The results from antibody tests can help us better understand questions about exposure to COVID-19.
  • On June 3, 2020, the FDA approved an abbreviated new drug application for dexmedetomidine hydrochloride in 0.9% sodium chloride injection (ANDA 209307), indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting and sedation of non-intubated patients prior to and/or during surgical and other procedures.

    The most common side effects of dexmedetomidine hydrochloride injection are hypotension, bradycardia and dry mouth.

    This drug is listed in the FDA Drug Shortage Database. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to medical products to help address the critical needs of the American public.
  • As part of FDA’s effort to protect consumers, the agency issued warning letters to operators of four websites (www.roidsmall.net, www.emedkit.com, www.4nrx.md and www.chloroquineonline.com) that market unapproved and misbranded COVID-19 products.

    There are currently no FDA-approved drugs to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.

    Consumers can visit BeSafeRx to learn about how to safely buy medicine online.
  • Today, the FDA announced that on Tuesday, June 9, 12:00 pm – 1:00 pm ET, the FDA will launch a webinar series on the topic of Respirators for Health Care Personnel Use during COVID-19 Pandemic.

    The webinar will provide FDA information and answer questions about emergency use authorizations (EUAs) for respirators, importing respirators, and overall FDA actions to help ensure that health care personnel on the front lines have the necessary supplies of respirators to meet the demand.

    Hear from speakers, including Stephen M. Hahn, MD, Commissioner of Food and Drugs at the FDA; Jeffrey E. Shuren, MD, JD, Director of the Center for Devices and Radiological Health (CDRH) at the FDA; William H. Maisel, MD, MPH, Director, Office of Product Evaluation and Quality (OPEQ) at CDRH; and Suzanne Schwartz, MD, MBA, Director, Office of Strategic Partnerships and Technology Innovation (OST) at CDRH.

    We encourage all interested stakeholders to join. Registration is not necessary.
  • Today, the FDA issued a letter to clinical laboratory staff and health care providers about a safety risk with using transport media and SARS-CoV-2 testing platforms that are not compatible.

    There is a risk of exposure to harmful cyanide gas when certain transport media are used with an incompatible testing platform or laboratory process that uses bleach.
  • Today, the FDA publicly posted test performance data from four more antibody, or serology, test kits on open.fda.gov from its independent performance validation study effort with the National Institutes of Health’s (NIH) National Cancer Institute (NCI).

    These results are among the first to come from a collaborative effort by the FDA, NIH, Centers for Disease Control and Prevention (CDC) and the Biomedical Advanced Research and Development Authority (BARDA).

    Additional performance data will be made available as the FDA reviews and determines if any further actions are appropriate for those test kits prior to publication.
  • Testing updates:
    • During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted or said they will be submitting, EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
    • To date, the FDA has authorized 120 tests under EUAs, which include 104 molecular tests, 15 antibody tests, and 1 antigen test.

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-june-4-2020

The big twist on the largest clinical trial with Hydroxychloroquine

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The big twist on the largest clinical trial with Hydroxychloroquine
June 03, 2020: The Lancet retracted the biggest study published regarding Hydroxychloroquine use for the treatment of COVID19.

“This study included all patients hospitalized at registry participating hospitals and with PCR-confirmed COVID-19 infection between Dec 20, 2019, and April 14, 2020, for whom a clinical outcome of either hospital discharge or death was recorded during hospitalization.”

96 032 hospitalized patients from 671 hospitals were infected with COVID-19 between 20 Dec 2019 and 14 April 2020 and fulfilled the requirements for inclusion in this report.

The Lancet comments as “Important scientific questions have been raised about data reported in the paper by Mandeep Mehra et al—Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis—published in The Lancet on May 22, 2020.

Although an independent audit of the provenance and validity of the data has been commissioned by the authors not affiliated with Surgisphere and is ongoing, with results expected very shortly, we are issuing an Expression of Concern to alert readers to the fact that serious scientific questions have been brought to our attention.”

https://www.thelancet.com/journals/lanpub/article/PIIS0140-6736(20)31290-3/fulltext

Data from RINVOQ&#Phase 3 Studies Presented at 2020 Annual European E-Congress of Rheumatolo

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Data from RINVOQ&#Phase 3 Studies Presented at 2020 Annual European E-Congress of Rheumatolo
 June 04, 2020: “AbbVie, a research-based global biopharmaceutical company announced new long-term results showing that once daily upadacitinib continued to improve signs and symptoms in patients with rheumatoid arthritis at 72 and 84 weeks in the SELECT-COMPARE (upadacitinib, 15 mg in combination with methotrexate [MTX]) and SELECT-MONOTHERAPY (upadacitinib, 15 mg and 30 mg) Phase 3 clinical trials, respectively.

The safety profile of upadacitinib (15 mg and 30 mg) monotherapy or upadacitinib (15 mg) in combination with MTX was consistent with that observed in the previously reported integrated Phase 3 safety analysis in rheumatoid arthritis, with no new safety risks detected.

Additionally, approximate two-year data (96 weeks) from the SELECT-EARLY (upadacitinib, 15 mg and 30 mg) and SELECT-COMPARE clinical trials showed that upadacitinib was effective in inhibiting structural joint damage as monotherapy or in combination with MTX.

Full results were presented today at the 2020 Annual European E-Congress of Rheumatology (EULAR).

RINVOQ™, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is approved as an oral, once-daily, 15 mg therapy for adults with moderate to severely active rheumatoid arthritis.

“These new long-term data showcase the potential of RINVOQ to provide relief from the signs and symptoms of rheumatoid arthritis, both as a monotherapy and in combination with methotrexate,” said Isidro Villanueva, vice president, medical affairs immunology, AbbVie.

“We are excited to share these results with the rheumatology community reinforcing RINVOQ as an important treatment option that may help more patients living with rheumatoid arthritis reach their goals in disease management.”

RINVOQ™ (upadacitinib, 15 mg)

Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.

In August 2019, RINVOQ received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

In December 2019, RINVOQ was approved by the European Commission for the treatment of adult patients with moderate to severely active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs.

The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Phase 3 trials of RINVOQ in rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, Crohn’s disease, atopic dermatitis, ulcerative colitis and giant cell arteritis are ongoing.

SELECT-COMPARE

SELECT-COMPARE is a Phase 3, multicenter, randomized, double-blind study designed to evaluate the safety and efficacy of RINVOQ compared to placebo and adalimumab in adult patients with moderate to severe active rheumatoid arthritis who had an inadequate response to methotrexate and continued a stable background of MTX.

Patients received background MTX and were randomized 2:2:1 to receive RINVOQ (15 mg, once daily), placebo or adalimumab (given as a subcutaneous injection of 40 mg every other week).

The primary endpoints of the first phase included the percentage of subjects achieving ACR20 and clinical remission (based on DAS28-CRP) after 12 weeks of treatment compared to placebo.

Ranked secondary endpoints included change in the mTSS compared to placebo and a comparison versus adalimumab in percentage of subjects achieving ACR50, low disease activity, changes in pain as measured by the Patient’s Assessment of Pain (based on VAS) and changes in physical function, as measured by the Health Assessment Questionnaire-Disability-Index (HAQ-DI).

The trial is ongoing and included a 48-week randomized, double-blind treatment period followed by a long-term extension study of up to five years.”
https://news.abbvie.com/news/press-releases/new-long-term-data-from-rinvoq-upadacitinib-15-mg-phase-3-studies-in-rheumatoid-arthritis-presented-at-2020-annual-european-e-congress-rheumatology-eular.htm

Coronavirus (COVID-19) Update: Daily Roundup June 3, 2020

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Coronavirus (COVID-19) Update: Daily Roundup June 3, 2020
June 03, 2020: “The U.S. FDA announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
  • The FDA announced a new web-based resource, titled Testing Supply Substitution Strategies.

    This 22-slide PowerPoint file contains detailed information to help support labs performing authorized COVID-19 tests.

    This interactive tool includes validated supply alternatives that labs can use to continue performing testing when there is a supply issue with some components of a test.

    The information in this resource is not intended to alter any already issued EUA for a COVID-19 diagnostic test nor is it intended to speak to any specific FDA regulatory requirement.

    Rather, the information is being provided to help address availability concerns regarding certain critical components of COVID-19 diagnostic tests during this pandemic.

    To navigate through the strategies in the file, download the file, open it, and click Slide Show > From Beginning.
  • The FDA added content to the question-and-answer appendix in its guidance titled Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.

    The updated guidance has a new question-and-answer pertaining to 21 CFR Part 11 compliance for electronic systems used to generate electronic signatures on clinical trial records.

    The guidance cites the COVID MyStudies App as an example of an electronic method for obtaining informed consent securely when face-to-face contact is not possible.

    In addition, the guidance further expands on an existing question-and-answer about remote clinical outcomes assessments (COAs) to include four types of COAs: performance outcomes, interview-based clinician-reported outcomes, patient-reported outcomes, and observer-reported outcomes.
  • Today, the FDA issued an alert to health care professionals regarding a temporary absence of the “paralyzing agent” warning statement on the vial caps of two neuromuscular blocking agents: vecuronium bromide for injection and rocuronium bromide injection.

    The temporary distribution helps increase the supply of these high-demand drugs used in patients requiring medical ventilation.

    Related News: Coronavirus (COVID-19) Update: Daily Roundup June 2, 2020
  • Testing updates:
    • During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted, or said they will be submitting, EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
    • To date, the FDA has authorized 120 tests under EUAs, which include 104 molecular tests, 15 antibody tests, and 1 antigen test.

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-june-3-2020

Novartis PREVENT data show Cosentyx® for relief in axial spondyloarthritis

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Novartis PREVENT data show Cosentyx® for relief in axial spondyloarthritis
June 4, 2020: “Novartis, a leader in rheumatology and immuno-dermatology announced the full 52-week results from the Phase III PREVENT trial, which reinforce the substantial and sustained benefits of Cosentyx® (secukinumab) across the axial spondyloarthritis (axSpA) spectrum.

The study found patients treated with Cosentyx 150 mg showed significant and sustained improvements in signs and symptoms of non-radiographic axial spondyloarthritis (nr-axSpA) at 52 weeks. nr-axSpA is a painful and debilitating condition affecting 1.7 million people in the top five EU countries and the US.

However, because nr-axSpA is underdiagnosed, with an average delay in diagnosis of more than seven years, that number may be higher3.

“Axial spondyloarthritis can have a serious impact on a patient’s quality of life and ability to carry out everyday tasks.

PREVENT demonstrated the efficacy and safety of secukinumab in non-radiographic axial spondyloarthritis, showing early and sustained relief from the signs and symptoms of this often painful disease,” said Jürgen Braun, MD, Professor of Rheumatology at Ruhr-University Bochum, Germany, and an investigator in the secukinumab clinical trial program.

The PREVENT trial met its primary endpoint of 40% improvement in the Assessment of Spondyloarthritis International Society (ASAS40) in biologic treatment-naïve patients at Week 16 and Week 52 versus placebo (41.5% vs 29.2%: P<0.05 and 35.4% vs 19.9%: P<0.05), respectively when a loading dose was used.

Secondary endpoints indicating improvements in pain, mobility and health-related quality of life were also met in the trial up to Week 52. The trial demonstrated a safety profile consistent with previous clinical trials with no new safety signals reported.

Related news: Novartis Cosentyx® gains fourth indication in EU with first-in-class approval in axial spondyloarthritis spectrum

The PREVENT data are being presented at the Annual European Congress of Rheumatology (EULAR) e-congress 2020.

“With these new data and the recent first-in-class European approval of Cosentyx in non-radiographic axial spondyloarthritis, we are continuing to build on our heritage in the axial spondyloarthritis disease spectrum,” said Eric Hughes, Global Development Unit Head, Immunology, Hepatology & Dermatology at Novartis.

“This fourth indication for Cosentyx further demonstrates our commitment to reimagine care for more patients.”

Cosentyx is the first fully-human interleukin (IL)-17A inhibitor indicated for patients in Europe with nr-axSpA and is backed by five years of clinical data supporting long-term safety and efficacy across moderate-to-severe plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS).

In April 2020, Novartis received approval of Cosentyx from the European Commission for the treatment of nr-axSpA.

Novartis has also submitted Cosentyx for review by the US Food and Drug Administration (FDA) and the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with nr-axSpA.  

About axSpA
AxSpA is a spectrum of long-term inflammatory disease characterized by chronic inflammatory back pain.

The axSpA spectrum includes AS, in which joint damage is generally visible on X-ray, and nr-axSpA, in which joint damage is not visible on X-ray.

Both parts of the disease spectrum have a comparable symptom burden, including nocturnal waking caused by pain, spinal pain, morning stiffness, fatigue and functional disability.

If left untreated, axSpA impairs activity, leads to lost work time and has a significant impact on quality of life, including family relationships.

Cosentyx
Cosentyx is the first and only fully-human biologic that directly inhibits IL-17A, a cornerstone cytokine involved in the inflammation and development of PsO, PsA and AS.

Cosentyx is backed by robust clinical evidence, including five-year data across three indications of PsO, PsA and AS, as well as data from real-world evidence.

These data strengthen the unique position of Cosentyx as a rapid and long-lasting comprehensive treatment across axSpA, PsA and psoriatic disease, with more than 300,000 patients treated worldwide with Cosentyx since launch.

PREVENT
PREVENT is an ongoing two-year randomized, double-blind, placebo-controlled Phase III study (with a two-year extension phase) to investigate the efficacy and safety of Cosentyx in patients with active nr-axSpA.

The study enrolled 555 male and female adult patients with active nr-axSpA (with onset before 45 years of age, spinal pain rated as >=40/100 on a visual analog scale (VAS) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4) and who had been taking at least two different non-steroidal anti-inflammatory drugs (NSAIDs) at the highest dose up to 4 weeks prior to study start.

Patients may have previously taken a TNF inhibitor (not more than one) but had an inadequate response. Of the 555 patients enrolled in the study, 501 (90.3%) were biologic-naïve.

Patients were allocated to one of three treatment groups: Cosentyx 150 mg subcutaneously with a loading dose (induction: 150 mg secukinumab subcutaneously weekly for 4 weeks, then maintenance with 150 mg secukinumab monthly); Cosentyx 150 mg no loading dose (150 mg secukinumab subcutaneously monthly), or placebo (induction of subcutaneously weekly for 4 weeks, followed by maintenance of once-monthly).

The primary endpoints are the proportion of patients achieving an ASAS40 response with Cosentyx 150 mg at Weeks 16 and 52 in TNF-naive patients.

Secondary endpoints include among others change in BASDAI over time and change in the Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP).”
https://www.novartis.com/news/media-releases/novartis-prevent-data-show-cosentyx-helps-patients-realize-early-and-lasting-relief-axial-spondyloarthritis

Complete results from study of Pfizer’s abrocitinib published in jama dermatology

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Complete results from study of Pfizer’s abrocitinib published in jama dermatology

June 03, 2020: “Pfizer Inc. announced that JAMA Dermatology has published complete results from the second Phase 3 monotherapy pivotal study (JADE MONO-2) of abrocitinib, an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor, in patients aged 12 and older with moderate to severe atopic dermatitis (AD).

Consistent with the first Phase 3 monotherapy study (JADE MONO-1), both doses of abrocitinib met all co-primary and key secondary endpoints and were generally well tolerated.

“Results from the second pivotal trial for abrocitinib reinforce the potential symptom relief it can offer those living with moderate to severe atopic dermatitis, including for itch — one of the most bothersome symptoms of AD,” said Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development.

“We are hopeful that these findings, should abrocitinib be approved, will translate into meaningful improvements for patients who face daily challenges with this disease.”

JADE MONO-2 Trial Design

JADE MONO-2 was a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of two doses (100mg and 200mg once daily) of abrocitinib monotherapy over 12 weeks.

A total of 391 subjects with moderate to severe atopic dermatitis were randomized to abrocitinib 200mg, abrocitinib 100mg, and placebo in the trial.

Efficacy endpoints evaluated measures of improvements in skin clearance, disease extent and severity, and itch. The co-primary study endpoints in JADE MONO-2 were the proportion of patients who achieved:

  • an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) skin and two-point or greater improvement relative to baseline at Week 12.
  • at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI) score at Week 12.

The key secondary endpoint was the proportion of patients achieving a four-point or larger reduction in itch severity measured with the Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 2, 4, and 12.

The proportion of patients who achieved a 90% or greater change from baseline in EASI score at Week 12 was included as a secondary endpoint.

JADE MONO-2 Study Efficacy Results

Abrocitinib

Abrocitinib is an oral small molecule that selectively inhibits Janus kinase (JAK) 1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of atopic dermatitis, including interleukin (IL)-4, IL-13, IL-31, IL-22 and thymic stromal lymphopoietin (TSLP).

Abrocitinib received Breakthrough Therapy designation from the FDA for the treatment of patients with moderate to severe AD in February 2018. Breakthrough Therapy designation was initiated as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) signed in 2012.

As defined by the FDA, a breakthrough therapy is a drug intended to be used alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.

If a drug is designated as a Breakthrough Therapy, the FDA will expedite the development and review of such drug.

Atopic Dermatitis

AD is a chronic skin disease characterized by inflammation of the skin and skin barrier defects.

Lesions of AD are characterized by erythema (redness), itching, induration (hardening)/papulation (formulation of papules), and oozing/crusting.

AD is one of the most common, chronic, relapsing childhood dermatoses, affecting up to 10% of adults and up to 20% of children worldwide.”

https://www.pfizer.com/news/press-release/press-release-detail/complete-results-second-pivotal-monotherapy-study

Roche’s Elecsys IL-6 test receives FDA Authorisation for severe inflammatory response

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Roche’s Elecsys IL-6 test receives FDA Authorisation for severe inflammatory response
June 04, 2020: “Roche announced that the U.S. FDA has issued an Emergency Use Authorisation (EUA) for the Elecsys® IL-6 test.

This test measures levels of the biomarker interleukin 6 (IL-6) and can be used to help identify patients with confirmed COVID-19 disease who could be at high risk of intubation with mechanical ventilation.

The test can support physicians, in combination with other examinations and vital signs, to decide early on if a patient with confirmed COVID-19 illness requires mechanical ventilation.

“The FDA EUA approval of Elecsys IL-6 is another step in our commitment to deliver fast and reliable diagnostic tests to help fight the coronavirus pandemic,” said Thomas Schinecker, CEO Roche Diagnostics.

“In the current situation, time is specifically critical. The test could help physicians in the quick identification of severe inflammatory response in patients infected with the SARS CoV-2 virus.”

“In the current pandemic, Roche’s Elecsys IL-6 test was helpful as an early indicator for acute inflammation and in the management of critically ill patients,” said Tobias Herold, MD from the Emergency Department, University Hospital, LMU University Munich, Germany.

“Elevated IL-6 values help us to identify patients with a high risk of upcoming respiratory failure.

Hospitals and reference laboratories can run the Elecsys IL-6 test on Roche’s cobas e® analysers which are widely available around the world.

These fully-automated systems can provide test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyser.

Elecsys IL-6
The IL-6 immunoassay is an in vitro diagnostic test for the quantitative determination of IL-6 (interleukin-6) in human serum or plasma.

This assay is used in countries accepting CE-mark to aid in the management of critically ill patients, as an early indicator for acute inflammation.

Under the Emergency Use Authorisation in the US, this assay can be used to assist in identifying severe inflammatory response in patients with confirmed COVID‑19 illness to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing.

IL-6 is released by immune cells, once they are activated by virus, bacteria or other immune cells. IL-6 acts like a messenger to activate other immune cells to fight the infection.

Because IL-6 is released so early during severe infection, it helps physicians to identify severely ill COVID-19 patients as early as possible.

Hospitals and reference laboratories can run the test on Roche’s cobas e analysers which are widely available around the world. These fully-automated systems can provide test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyser.

Related News: Roche initiates phase III clinical trial of Actemra/RoActemra plus remdesivir

Roche initiates Phase III clinical trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 pneumonia

Roche’s response to the COVID-19 pandemic
The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need.

Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 13 March we received FDA Emergency Use Authorisation for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, which is also available in countries accepting the CE Mark.

On 3 May, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorisation and is available in markets accepting the CE mark.

Our existing diagnostics portfolio for critical care has also been playing a significant role in supporting patient management during the COVID-19 crisis, with our blood gas and sepsis products being used to monitor patients in the acute setting.

Roche is working closely with governments and health authorities around the world and has significantly increased production to help ensure availability of tests globally.

While there are currently no approved medicines for the treatment of patients with COVID-19, we are actively involved in understanding the potential of our existing portfolio and are researching options for the future.

On 19 March, we announced the initiation of COVACTA – a global Phase III randomised, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of intravenous Actemra©/RoActemra© (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care.

Roche has also initiated an internal early research programme focused on the development of medicines for COVID-19 and is evaluating a large number of potential collaborations.

In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.”
https://www.roche.com/media/releases/med-cor-2020-06-04.htm

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