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Positive Top-Line Results From Pfizer’s Phase 3 JADE DARE Trial for Atopic Dermatitis

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Positive Top-Line Results From Pfizer’s Phase 3 JADE DARE Trial for Atopic Dermatitis

August 30, 2021: “Pfizer Inc. announced that JADE DARE (B7451050), a 26-week, randomized, double-blind, double-dummy, active-controlled, multi-center Phase 3 study, met its co-primary and key secondary efficacy endpoints.

The study showed that abrocitinib was statistically superior compared to dupilumab in each evaluated efficacy measure and had a safety profile consistent with previous studies.

The head-to-head study was designed to directly compare the efficacy of abrocitinib 200mg versus dupilumab 300mg, in adult participants on background topical therapy with moderate to severe atopic dermatitis (AD).

Abrocitinib 200mg was administered by once-daily oral tablet and dupilumab was administered by subcutaneous injection every other week following a 600mg induction dose.

“The results from our first formal head-to-head trial for abrocitinib illustrate its potential for meaningful symptom relief for patients and further build upon the substantial body of data from the JADE development program,” said Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development.

“We’re pleased that the study findings show the potential impact abrocitinib could have to help people living with moderate to severe atopic dermatitis in reducing their itch significantly and in achieving near complete skin clearance.”

The co-primary efficacy endpoints in JADE DARE were the proportion of patients achieving at least a 4-point improvement in the severity of Peak Pruritus Numerical Rating Scale (PP-NRS4) from baseline at Week 2 and the proportion of patients achieving Eczema Area and Severity Index (EASI)-90 (≥90% improvement from baseline) at Week 4.

The key secondary endpoint was the proportion of patients achieving EASI-90 at Week 16. The study will allow assessment of any difference in efficacy that may persist at month 6 of treatment.

A larger percentage of patients treated with abrocitinib 200mg experienced adverse events compared to dupilumab 300mg.

The proportion of patients experiencing serious adverse events, severe adverse events, and adverse events leading to study discontinuation were similar in both treatment arms.

Two deaths occurred in patients treated with abrocitinib 200mg, which were characterized by the investigator as unrelated to the study drug.

One death was attributed to COVID-19 and the second was attributed to intracranial hemorrhage and cardiorespiratory arrest, and classified as a major adverse cardiovascular event (MACE).

There were no cases of malignancies or venous thromboembolism (VTE) events confirmed through adjudication. The safety profile seen with abrocitinib was consistent with previous studies in the JADE program.

The study is part of the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program for abrocitinib.

Full results from JADE DARE will be submitted for presentation at a future scientific meeting and publication in a medical journal.

Additionally, at the appropriate time, Pfizer intends to share these data with the U.S. Food and Drug Administration (FDA) and other regulatory agencies around the world reviewing submissions for abrocitinib.

About Abrocitinib

Abrocitinib is an oral small molecule that selectively inhibits Janus kinase (JAK).

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).”

https://www.pfizer.com/news/press-release/press-release-detail/positive-top-line-results-pfizers-phase-3-jade-dare-trial

Pfizer and BioNTech Announce Collaboration With Brazil’s Eurofarma

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Pfizer and BioNTech Announce Collaboration With Brazil’s Eurofarma

August 26, 2021: “Pfizer and BioNTech announced the signing of a letter of intent with Eurofarma Laboratórios SA, a Brazilian biopharmaceutical company, to manufacture COMIRNATY® (COVID-19 Vaccine, mRNA) for distribution within Latin America.

Eurofarma will perform manufacturing activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network, which will now span four continents and include more than 20 manufacturing facilities.

To facilitate Eurofarma’s involvement in the process, technical transfer, on-site development, and equipment installation activities will begin immediately.

Per the agreement, Eurofarma will obtain drug product from facilities in the U.S., and manufacturing of finished doses will commence in 2022.

At full operational capacity, the annual production is expected to exceed 100 million finished doses annually. All doses will exclusively be distributed within Latin America.

“Everyone – regardless of financial condition, race, religion or geography – deserves access to lifesaving COVID-19 vaccines,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

“Our new collaboration with Eurofarma expands our global supply chain network to another region – helping us continue to provide fair and equitable access to our COVID-19 vaccine. We will continue to explore and pursue opportunities such as this to help ensure that vaccines are available to all who are in need.”

“We have been continuously increasing the manufacturing capacity of our own facilities and included dozens of manufacturing partners into our global network.

Together with Pfizer, we have delivered more than 1.3 billion doses and we plan to deliver 3 billion doses in total by the end of the year.

Today’s partnership is an important step to broaden the access to vaccines in Latin America and beyond by expanding our global manufacturing network,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.

“We will continue to enable people worldwide to manufacture and distribute our vaccine while ensuring the quality of the manufacturing process and the doses.”

“At such a difficult time as this one, being able to share this news fills us with pride and hope.

Eurofarma is about to turn 50 years old and signing this collaboration in the production of the COVID-19 vaccine represents another milestone in our trajectory.

We are making available our best resources in terms of industrial capacity, technology and quality to this project, so that we can meet the contract with excellence and contribute to supplying the Latin American market,” said Maurízio Billi, President, Eurofarma.

Pfizer and BioNTech select contract manufacturers using a rigorous process based on several factors: quality, compliance, safety track record, technical capability, capacity availability, highly trained workforce, project management abilities, prior working relationship, and commitment to working with flexibility through a fast-paced program.

To date, Pfizer and BioNTech have shipped more than 1.3 billion COVID-19 vaccine doses to more than 120 countries and territories in every region of the world.

The companies are firmly committed to working towards equitable and affordable access for COVID-19 vaccines for all people around the world, actively working with global governments and global health partners with the aim to provide 2 billion doses to low and middle income countries in 2021 and 2022 – 1 billion each year.

This includes direct supply agreements with individual country governments; an agreement to supply 500 million doses to the U.S. Government at a not-for-profit price, which the government will, in turn, donate to the African Union and the COVAX 92 Advanced Market Commitment (AMC) countries; and a direct supply agreement with COVAX for 40 million doses in 2021.

COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer.

BioNTech is the Marketing Authorization Holder in the United States, the European Union and the United Kingdom, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer), Canada and other countries.

Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

U.S. Indication & Authorized Use

COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

  • It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older
  • It is also authorized under Emergency Use Authorization (EUA) to be administered for emergency use to:
    • prevent COVID-19 in individuals 12 through 15 years, and
    • provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise

The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to:

  • prevent COVID-19 in individuals 12 years of age and older, and
  • provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise

The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.

An individual may be offered either COMIRNATY® (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.

EUA Statement

This emergency use of the product has not been approved or licensed by FDA, but has been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

Important Safety Information

Individuals should not get the Pfizer-BioNTech COVID-19 Vaccine if they:

  • had a severe allergic reaction after a previous dose of this vaccine
  • had a severe allergic reaction to any ingredient of this vaccine

Individuals should tell the vaccination provider about all of their medical conditions, including if they:

  • have any allergies
  • have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
  • have a fever
  • have a bleeding disorder or are on a blood thinner
  • are immunocompromised or are on a medicine that affects the immune system
  • are pregnant, plan to become pregnant, or are breastfeeding
  • have received another COVID-19 vaccine
  • have ever fainted in association with an injection

The vaccine may not protect everyone.

Side effects reported with the vaccine include:

  • There is a remote chance that the vaccine could cause a severe allergic reaction
    • A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the vaccine.

      For this reason, vaccination providers may ask individuals to stay at the place where they received the vaccine for monitoring after vaccination
    • Signs of a severe allergic reaction can include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness
    • If an individual experiences a severe allergic reaction, they should call 9-1-1 or go to the nearest hospital
  • Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine.

    In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine.

    The chance of having this occur is very low. Individuals should seek medical attention right away if they have any of the following symptoms after receiving the vaccine:
    • chest pain
    • shortness of breath
    • feelings of having a fast-beating, fluttering, or pounding heart
  • Side effects that have been reported with the vaccine include:
    • severe allergic reactions; non-severe allergic reactions such as rash, itching, hives, or swelling of the face; myocarditis (inflammation of the heart muscle); pericarditis (inflammation of the lining outside the heart); injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); diarrhea; vomiting; arm pain
  • These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The vaccine is still being studied in clinical trials.

    Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.”

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210826005385/en/

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-collaboration-brazils

Innovative ICR-discovered drug to enter first clinical trial, targeting HSF1 pathway

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Innovative ICR-discovered drug to enter first clinical trial, targeting HSF1 pathway

August 26, 2020: “Cancer patients are set to receive, for the first time, a highly innovative investigational drug called NXP800 – which was discovered at The Institute of Cancer Research, London – in a phase I clinical trial sponsored by an oncology-focused biopharmaceutical company, Nuvectis Pharma.

The investigational oral drug inhibits the so-called Heat Shock Factor-1 (HSF1) pathway, and was discovered by scientists at the Cancer Research UK Cancer Therapeutics Unit at The Institute of Cancer Research (ICR).

The first-in-human study is due to begin later this year.

New cancer trial

The phase I trial will be led by Professor Udai Banerji, Deputy Director of Drug Development at the ICR and The Royal Marsden NHS Foundation Trust, in patients with advanced cancers from The Royal Marsden.

The ICR’s expert teams in pharmacodynamics and pharmacokinetics will lead on gathering data on the body’s handling of NXP800 and its biological effects – providing biomarkers that form a ‘Pharmacological Audit Trail’ of the drug’s behaviour.

As a ‘transcription factor’, HSF1 is a master switch that controls the activity of genes in the cell. In healthy cells HSF1 activates a specific gene programme in response to certain types of cellular stress.

Hijacked gene activation

But in cancers, HSF1 is hijacked and its gene activation programme is modified in a way that is needed by the tumour cells to survive, grow and spread.

Cancer cells are subject to a range of stresses and the modified HSF1 gene activation programme helps them to overcome these.

Patients with high levels of HSF1 gene activation in their cancers have poorer overall survival.

The trial follows a long-running research project from a team of scientists at the ICR led by Professor Paul Workman, with earlier work funded by organisations including the Battle Against Cancer Investment Trust (BACIT).

The medicinal chemistry component of the multidisciplinary research was led by Professor Keith Jones.

Our researchers work with industry partners to discover and optimise new cancer drugs and take them into clinical trials.

While transcription factors are traditionally known to be very difficult to target directly with drugs, scientists at the ICR identified a small molecule that inhibits HSF1’s gene activation programme.

They did this by using cellular ‘phenotypic screening’ – involving the testing of hundreds of thousands of chemical compounds for their ability to switch off the HSF1 gene activation programme in live cancer cells in culture. This was followed by medicinal chemistry to optimise the handling of the drug in the body.

Ovarian and endometrioid cancers

In pre-clinical studies, NXP800 was shown to potently block human cancer cell growth in culture and cause regression of tumours in mice – with hard-to-treat ovarian clear cell carcinoma (OCCC) and endometrioid ovarian cancers being the most sensitive to treatment.

Nuvectis has licensed worldwide development and commercialization rights to the HSF1 drug candidate NXP800 from its previous commercial investor, the CRT Pioneer Fund (CPF) managed by Sixth Element Capital.

Nuvectis has also today announced the completion of a $15 million Series A Preferred Stock financing with institutional and private investors.

Professor Paul Workman, Chief Executive of The Institute of Cancer Research, London, and the originator and leader of its HSF1 programme, said:

“We’re enormously excited to see our new first-in-class HSF1 pathway inhibitor drug is on the cusp of reaching clinical trials, thanks to this new partnership with the highly experienced team at Nuvectis. This is following a long-running and highly innovative team science project at ICR to discover an oral clinical candidate in partnership with the CPF.

“This is a prime example of the original and creative drug discovery and development that is possible through synergistic partnerships between academics, clinicians and private enterprise and that could lead to a totally new type of treatment for patients with hard-to treat cancers.”

Professor Udai Banerji, Deputy Director of Drug Development at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, said:

“NXP800 is an innovative first-in-class drug and we are excited to be nearing the stage of the drug development pathway when patients will start receiving it. This phase I trial will aim to establish a safe dose and dosing schedule for NXP800, as well as provide initial evidence of its clinical activity in a range of cancer types – and we hope that it will lead on to late-stage clinical development.”

Bridging the gap between drug discovery and clinical trials

Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, said:

“We are excited to have partnered with the ICR and CPF on this important project.  We believe that NXP800 has the potential to become a first-in-class HSF-1 pathway inhibitor and benefit patients suffering from OCCC, late-stage endometroid ovarian as well as other types of cancers. We look forward to the pending commencement of the phase I study in the capable hands of the ICR and The Royal Marsden.”

Dr Robert James, Managing Partner at Sixth Element Capital, said: 

“We are delighted to have partnered NXP800 with Nuvectis and that this very novel agent will now march forward into clinical evaluation for the benefit of the cancer patients.

This is a further exemplification of the CRT Pioneer Fund’s successful investment strategy to develop and commercialise early stage and highly innovative cancer therapies.”

Tony Hickson, Chief Business Officer at Cancer Research UK, said:

“Projects like this demonstrate exactly what we wanted to achieve when setting up the CRT Pioneer Fund – seamlessly bridging the gap between drug discovery and clinical trials so we can bring innovative treatments to people with cancer in the safest and quickest time possible.”

“We are looking forward to seeing the results of the upcoming phase 1 clinical trial and hope to one day see it benefit patients with a range of hard-to-treat cancer types.”

https://www.icr.ac.uk/news-archive/innovative-icr-discovered-drug-to-enter-first-clinical-trial-targeting-hsf1-pathway

Coronavirus (COVID-19) Daily Update: August 27, 2021

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Coronavirus (COVID-19) Daily Update: August 27, 2021

August 27, 2021: “The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • On August 25, the FDA issued a Letter to Health Care Providers alerting health care facility risk managers, procurement staff and health care personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacture Co., Ltd. (Shanghai Dasheng).

    The Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health (NIOSH) revoked all respirator approvals previously issued to Shanghai Dasheng because the firm did not implement, maintain and control a quality management system.

    All previously authorized Shanghai Dasheng respirators are no longer authorized for emergency use as a result of the loss of NIOSH-approval.
  • As part of the FDA’s effort to protect consumers from products making unproven claims about mitigating, preventing, treating, diagnosing or curing COVID-19 in people, on August 24, the agency issued a warning letter to Invisi Smart Technologies for offering for sale adulterated and misbranded Invisi Smart Masks.

    Consumers concerned about COVID-19 should consult with their health care provider. 
  • Testing updates:
    • As of today, 407 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs).

      These include 285 molecular tests and sample collection devices, 88 antibody and other immune response tests and 34 antigen tests. There are 60 molecular authorizations and one antibody authorization that can be used with home-collected samples.

      There is one molecular prescription at-home test, three antigen prescription at-home tests, seven antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
    • The FDA has authorized 14 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 613 revisions to EUA authorizations.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-august-27-2021

BioNTech/Pfizer and Moderna Increases manufacturing capacity for COVID-19 vaccines

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BioNTech/Pfizer and Moderna Increases manufacturing capacity for COVID-19 vaccines

August 24, 2011: “EMA’s human medicines committee (CHMP) has adopted recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU.

Additional manufacturing site and scaled-up process for Comirnaty

CHMP has approved an additional manufacturing site for the production of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer. The site, located in Saint Rémy sur Avre, France, is operated by Delpharm and will manufacture finished product. The site will allow to provide approximately up to 51 million additional doses in 2021.

EMA has also approved a new manufacturing line at BioNTech’s manufacturing site in Marburg, Germany which increases the active substance manufacturing capacity by approximately 410 million doses in 2021.

Additional manufacturing site for Spikevax

CHMP has also approved an additional manufacturing site for the production of Spikevax, the COVID-19 vaccine developed by Moderna.

The site, located in Bloomington, Indiana, United States (US), is operated by Catalent. The site will perform finished product manufacturing.

In addition to the new manufacturing facility for this vaccine, CHMP has also approved several alternative sites responsible for batch control/testing and packaging of the finished product manufactured by Catalent.

On 30 July 2021, CHMP already approved a scale-up of the active substance manufacturing process at two sites in the US (Moderna TX, Inc., Norwood, Massachusetts and Lonza Biologics, Inc., Portsmouth, New Hampshire). All together, these changes are estimated to allow the production of 40 million additional doses of Spikevax to supply the EU market in the third quarter of 2021.

These recommendations do not require a European Commission decision and the sites can become operational immediately.

EMA is in continuous dialogue with all marketing authorisation holders of COVID-19 vaccines as they seek to expand their production capacity for the supply of vaccines in the EU.

The Agency provides guidance and advice on the evidence required to support and expedite applications to add new sites or increase the capacity of existing sites for the manufacture of high-quality COVID-19 vaccines.

https://www.ema.europa.eu/en/news/increase-vaccine-manufacturing-capacity-covid-19-vaccines-biontech-pfizer-moderna

FDA Approves First-of-Its-Kind Stroke Rehabilitation System

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FDA Approves First-of-Its-Kind Stroke Rehabilitation System

August 27, 2021: “The U.S. Food and Drug Administration approved the MicroTransponder Vivistim Paired VNS System (Vivistim System), a first-of-its-kind, drug-free rehabilitation system intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke—a stroke caused by a blockage of blood flow to the brain with long-lasting symptoms—using vagus nerve stimulation (VNS).

“People who have lost mobility in their hands and arms due to ischemic stroke are often limited in their treatment options for regaining motor function” said Christopher M. Loftus, M.D., acting director of the FDA’s Center for Devices and Radiological Health’s Office of Neurological and Physical Medicine Devices.

“Today’s approval of the Vivistim Paired VNS System offers the first stroke rehabilitation option using vagus nerve stimulation.

Used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke.”

A stroke occurs when blood flow to part of the brain is interrupted, causing brain cells to die from a lack of oxygen and nutrients contained in the blood.

There are different types of stroke, but the most common type is ischemic stroke, meaning the blood vessels to the brain become clogged, which blocks blood flow from reaching the brain.

Depending on how long the brain is deprived of blood and where in the brain the stroke occurs, stroke can lead to brain damage, temporary or permanent disabilities, and in some cases, death.

Disabilities resulting from stroke may include, but are not limited to, total or partial paralysis or difficulty with muscle movement.

The Vivistim System is intended to be used, along with post-stroke rehabilitation therapy, in patients who have had ischemic stroke, to electrically stimulate the vagus nerve—a nerve that runs from the brain down to the abdomen—to reduce deficiencies in upper limb and extremity motor function and to improve patients’ ability to move their arms and hands.

To use the Vivistim System, an implantable pulse generator (IPG)—which generates a mild electrical pulse—is implanted just under the skin in the chest of the patient.

Attached to the IPG is a lead wire that is implanted under the skin and leads up to electrodes that are placed on the left side of the neck where the vagus nerve is.

Accompanying the implantable components are clinician software preloaded onto a laptop and a wireless transmitter to be used only by a health care provider.

The software allows a health care provider managing a patient’s rehabilitation to input the appropriate settings on the IPG, including amplitude, frequency, and pulse width for the stimulation, and also records stimulation history, movements performed, and information about the IPG.

The wireless transmitter communicates adjustments to the IPG settings made using the software.

The Vivistim System, a prescription device, may be used in both clinical and at-home settings to provide VNS. If it is to be used during home rehabilitation exercises, the software and the wireless transmitter are not used by the patient.

However, the patient is supplied with a magnet that can be passed over the IPG implant site to activate the IPG to begin a 30-minute stimulation session during rehabilitative exercise.

When directed by a physician and with appropriate programming to the IPG, patients are trained on how to use the Vivistim System at home, as well as its safety features, to avoid any unwanted electrical stimulation.

The FDA evaluated the safety and effectiveness of the Vivistim System in a clinical study of 108 patients at 19 clinical sites in the U.S. and the U.K. who received the Vivistim System.

Patients were split into a study group (53 patients) and a control group (55 patients), whereby both groups were asked to complete 300-400 physical therapy exercises for 90 minutes a day, three times a week for six weeks.

The control group received only a very low level of VNS for the first five exercises of the 300-400-movement series and had no stimulation whatsoever for the rest of each session.

The treatment group received the appropriate amount of VNS throughout all 90-minute rehabilitation sessions.

Both groups received physical therapy sessions that were equivalent in quantity and quality. Following the initial six-week study, all patients received follow-up assessments at 1, 30, and 90 days following the study.

Effectiveness for the Vivistim System was measured using the Upper Extremity Fugl-Meyer Assessment (FMA-UE), a stroke specific measure of motor impairment. Progress was measured as an increase in motor function from baseline after six weeks of therapy.

Patients in the treatment group had an average score increase of 5 points, whereas patients in the control group had an average score increase of 2.4 points.

Additionally, 47.2% of those in the treatment group saw an improvement of 6 or more points in the FMA-UE score 90 days post-therapy as compared with 23.6% in the control group.

Adverse events included but were not limited to dysphonia (difficulty speaking), bruising, falling, general hoarseness, general pain, hoarseness after surgery, low mood, muscle pain, fracture, headache, rash, dizziness, throat irritation, urinary tract infection and fatigue.

The Vivistim System is not approved for use outside of its intended use to stimulate the vagus nerve during chronic ischemic stroke rehabilitation therapy for moderate to severe loss of upper extremity function. It should not be used in patients with vagotomy, which is surgical removal of part of the vagus nerve.

Patients should discuss with their providers any prior medical history of: other concurrent forms of brain stimulation; current diathermy treatment, which uses electrical current stimulation to produce “deep heating” beneath the skin in subcutaneous tissues, deep muscles and joints; depression or suicidality; schizophrenia, schizoaffective disorder, or delusional disorders; rapid cycling bipolar disorder; previous brain surgery or central nervous system injury; progressive neurological diseases other than stroke; cardiac abnormalities, including arrhythmia; dysautonomias, or medical conditions caused by problems with the autonomic nervous system; respiratory diseases or disorders, including dyspnea and asthma; ulcers; vasovagal syncope; and pre-existing hoarseness.

The Vivistim System was granted Breakthrough Device designation.

To qualify for such designation, a device must be intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition and meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives; or the availability of the device is in the best interest of patients.

The FDA reviewed the MicroTransponder Vivistim Paired VNS System under the Premarket Approval (PMA) pathway.

PMA is the most stringent type of device marketing application required by the FDA and is based on a determination by the FDA that the PMA application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use.

The MicroTransponder Vivistim Paired VNS System is manufactured by MicroTransponder Inc.”

https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-stroke-rehabilitation-system

J & J Announces Data to Support Boosting its Single-Shot COVID-19 Vaccine

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J & J Announces Data to Support Boosting its Single-Shot COVID-19 Vaccine

August 25, 2021: “Johnson & Johnson announced data supporting the use of its COVID-19 vaccine as a booster shot for people previously vaccinated with the single-shot Johnson & Johnson vaccine.

In July, the Company reported interim Phase 1/2a data published in the New England Journal of Medicine that demonstrated neutralizing antibody responses generated by the Johnson & Johnson single-shot COVID-19 vaccine were strong and stable through eight months after immunization.

In anticipation of the potential need for boosters, the Company conducted two Phase 1/2a studies in individuals previously vaccinated with its single-shot vaccine.

New interim data from these studies demonstrate that a booster dose of the Johnson & Johnson COVID-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination.

Significant increases in binding antibody responses were observed in participants between ages 18 and 55, and in those 65 years and older who received a lower booster dose.

The study summaries were submitted to medRxiv on August 24.

“We have established that a single shot of our COVID-19 vaccine generates strong and robust immune responses that are durable and persistent through eight months.

With these new data, we also see that a booster dose of the Johnson & Johnson COVID-19 vaccine further increases antibody responses among study participants who had previously received our vaccine,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson.

“We look forward to discussing with public health officials a potential strategy for our Johnson & Johnson COVID-19 vaccine, boosting eight months or longer after the primary single-dose vaccination.”

The Company is engaging with the U.S. Food and Drug Administration (FDA), U.S. Centers for Disease Control and Prevention (CDC), European Medicines Agency (EMA) and other health authorities regarding boosting with the Johnson & Johnson COVID-19 vaccine.

Johnson & Johnson continues to diligently generate and evaluate data from ongoing trials as well as emerging real-world evidence.

The Phase 1/2a clinical trials (VAC31518COV1001 and VAC31518COV2001) have been funded in part with federal funds from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under other transaction authority (“OTA”) agreement No. HHSO100201700018C.”

https://www.janssen.com/johnson-johnson-announces-data-support-boosting-its-single-shot-covid-19-vaccine

CDC identifies source in Salmonella outbreak linked to Italian-style meats

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CDC identifies source in Salmonella outbreak linked to Italian-style meats

August 26, 2021: “A CDC Food Safety Alert regarding a multistate outbreak of Salmonella infections has been posted: https://www.cdc.gov/salmonella/italian-style-meat-08-21/index.html

Key points:

  • Thirty-six people have been reported sick from 17 states and 12 people have been hospitalized. No deaths have been reported.
  • Interviews with sick people and shopper card records showed that most people ate Fratelli Beretta brand uncured antipasto trays before they got sick.
  • CDC is advising people to not eat Fratelli Beretta brand prepackaged uncured antipasto trays. Trays can include uncured salami, prosciutto, coppa, or soppressata. They were sold nationwide and have “best by” dates on or before February 11, 2022.
  • Italian-style meats sliced at a deli are not included in this alert.
  • The investigation is ongoing to determine if additional products are linked to illness.

What You Should Do:

  • Do not eat Fratelli Beretta brand prepackaged uncured antipasto trays with “best by” dates on or before February 11, 2022. Throw them away, even if some of them were eaten and no one got sick.
  • If you don’t know the brand of prepackaged Italian-style meats you have at home, don’t eat them and throw them away.
  • Wash items, containers, and surfaces that may have touched the products using hot soapy water or a dishwasher.

About Salmonella:

  • Most people infected with Salmonella develop diarrhea, fever, and stomach cramping 6 hours to 6 days after eating contaminated food.
  • The illness usually lasts 4 to 7 days, and most people recover without treatment.
  • In some people, the illness may be so severe that the patient is hospitalized. Salmonella infection may spread from the intestines to the bloodstream and then to other parts of the body.
  • Children younger than 5, adults 65 and older, and people with weakened immune systems are more likely to have severe illness.

If you have questions about cases in a particular state, please call that state’s health department.”

https://www.cdc.gov/media/releases/2021/s0826-salmonella-italian-style-meats.html

WHO issues rapid communication on updated guidance for management of TB

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WHO issues rapid communication on updated guidance for management of TB

August 26, 2021: “A rapid communication released by the World Health Organization (WHO) Global Tuberculosis Programme has announced important updates to guidance on the management of tuberculosis (TB) in children and adolescents.

This includes new recommendations on diagnostic options, treatment regimens, as well as treatment decision algorithms and optimal models of care for the delivery of child and adolescent TB services.

“Tuberculosis in children and adolescents has been overlooked for many years,  reflected in large gaps in access to TB prevention and care.

Therefore it is encouraging to see that options for the diagnosis, treatment, prevention and care for children and adolescents with TB or at risk of TB, are expanding, thanks to the generation of new evidence” said Dr Tereza Kasaeva, Director of WHO’s Global Tuberculosis Programme.

“We ask for ongoing commitment from country officials and stakeholders to prepare for and support the full implementation of new WHO recommendations on the management of TB in children and adolescents, which will soon be outlined in updated guidelines.”

The rapid communication highlights key updates including:

  • A recommendation on the use of Xpert MTB/ RIF Ultra in gastric aspirate or stool specimens as the initial diagnostic test for TB and the detection of rifampicin resistance, in children aged below 10 years with signs and symptoms of pulmonary TB.
  • A recommendation to use a 4-month treatment regimen (2HRZ(E)/2HR) rather than the standard 6-month regimen (2HRZ(E)/4HR) in children and adolescents under 16 years of age with non-severe, presumed drug-susceptible TB.
  • In children with MDR/ RR-TB of all ages:-        A recommendation to use bedaquiline as part of the shorter, all oral bedaquiline-containing regimen (conditionally recommended by WHO in 2020) or as part of longer treatment regimens.-       

    A recommendation to use delamanid as part of longer treatment regimens.-       

    These recommendations make it possible to design all-oral regimens for children of all ages.
  • A recommendation on the use of a shorter intensive regimen composed of 6 months of isoniazid, rifampicin, pyrazinamide and ethionamide in children and adolescents with microbiologically confirmed or clinically diagnosed TB meningitis, presumed to be drug susceptible, as an alternative to the currently recommended12 month regimen.
  • As well, treatment decision algorithms incorporating WHO recommended diagnostic tests may be used for children aged below 10 years with signs and symptoms of pulmonary TB. In addition, in high TB burden settings, decentralized and family-centred, integrated services may be implemented to improve TB case detection and the uptake of TB preventive treatment.

The rapid communication aims to inform staff from ministries of health and care providers across public and private sectors, technical partners and other stakeholders about the key findings, considerations and changes related to the diagnosis, treatment and care of TB for children and adolescents, in order to allow for planning at the country level ahead of the release of updated guidelines and an associated operational handbook.

Detailed recommendations will be published in the coming months as part of WHO’s Consolidated Guidelines on Tuberculosis, Module 5: Co-morbidities, Vulnerable Populations and People-centred Care, alongside a complementary operational handbook, which will contain implementation guidance.

The recommendations are based on the outcomes of a Guideline Development Group meeting.

https://www.who.int/news/item/26-08-2021-who-issues-rapid-communication-on-updated-guidance-for-the-management-of-tb-in-children-and-adolescents

FDA Releases PFAS Testing Results from First Survey of Nationally Distributed Processed Foods

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FDA Releases PFAS Testing Results from First Survey of Nationally Distributed Processed Foods

August 26, 2021: “The U.S. FDA released the results of the first survey of per- and polyfluoroalkyl substances (PFAS) in nationally distributed processed foods, including several processed baby foods, collected from the agency’s Total Diet Study (TDS), which monitors levels of nutrients and contaminants in foods consumed in the U.S. PFAS are chemicals found in a number of consumer and industrial products because of their resistance to grease, oil, water and heat.

Results of this survey showed that 164 of the 167 foods tested had no detectable levels of PFAS.

Three food samples collected as part of the FDA’s latest testing effort had detectable levels of PFAS: fish sticks, canned tuna and protein powder.

Based on the best available current science, the FDA has no scientific evidence that the levels of PFAS found in the samples tested indicate a need to avoid any particular food in the food supply.

“The FDA’s testing for certain PFAS in such a wide range of foods available, including those commonly eaten by babies and young children, is among the first study of its kind,” said Acting FDA Commissioner Janet Woodcock, M.D. “Although our studies to date, including these newly released results, do not suggest that there is any need to avoid particular foods because of concerns regarding PFAS contamination, the FDA will continue our work to better understand PFAS levels in the foods we eat to ensure the U.S. food supply continues to be among the safest in the world.”

The foods collected for the TDS represent the major components of the average diet of the U.S. population based on results of the national food consumption surveys.

The newly released results are from a survey that included nationally distributed processed foods, including certain baby foods, frozen foods and foods in cans, boxes or jars, which are less likely to vary by location or time of year and are generally considered non-perishable.

“Through testing foods in the general food supply for PFAS, consulting with states in circumstances where there may be local contamination of foods, and optimizing our methods for testing, the FDA is making progress in better understanding dietary exposure,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition.

“As we continue to collect and analyze the data being generated, we are in a better position to determine how to strategically and effectively work with our state and federal partners to reduce dietary exposure to PFAS.”

Since 2019, the FDA has analyzed 440 TDS samples for certain PFAS from four collections (three regional and one national).

Previously posted TDS survey results were from three regional collections and included foods that are more likely to vary by location or time of year, such as fresh produce, meats and dairy products.

The samples in the recent analysis were not specifically collected from areas of known environmental PFAS contamination.

While the FDA found detectable levels of PFAS in certain seafood samples in this survey, and in previous ones, the sample sizes are limited, and the results cannot be used to draw definitive conclusions about the levels of PFAS in seafood in the general food supply.

Importantly, as previously announced, the FDA is conducting a targeted survey of the most commonly consumed seafood in the U.S. Results from the targeted seafood survey will be used to determine if additional sampling, either targeted or with greater numbers of samples of fish and shellfish, is needed.

The FDA will continue to provide additional updates on its ongoing sampling and testing efforts designed to better understand the occurrence of PFAS in the food supply.

https://www.fda.gov/news-events/press-announcements/fda-releases-pfas-testing-results-first-survey-nationally-distributed-processed-foods

AZ’s Forxiga approved in Japan for treatment of chronic kidney disease

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AZ’s Forxiga approved in Japan for treatment of chronic kidney disease

August 26, 2021: “AstraZeneca’s Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in Japan for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D).

The approval by Japan’s Ministry of Health, Labour and Welfare (MHLW) is based on positive results from the DAPA-CKD Phase III trial.

The decision follows the Priority Review designation granted by the MHLW earlier this year.

CKD is a serious, progressive condition defined by decreased kidney function and is often associated with an increased risk of heart disease or stroke.

The condition affects 840 million people worldwide.

However, diagnosis rates remain low and up to 90% of patients are unaware they have the disease.4 Forxiga is the first ever approved medicine for the treatment of the disease in Japan.6,7

The national coordinator of the DAPA-CKD Phase III trial in Japan, Naoki Kashihara, President of the Japanese Society of Nephrology, said: “DAPA-CKD is the landmark trial that demonstrated unprecedented risk reduction for chronic kidney disease patients with and without type-2 diabetes.

This transformational milestone will bring great hope to many patients with chronic kidney disease in Japan.”

Related News: AstraZeneca’s First SGLT2 inhibitor Forxiga approved in China for heart failure

Forxiga approved in the EU for heart failure

Forxiga recommended for approval in the EU by CHMP for heart failure

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “This approval is an important step towards realising our ambition of improving outcomes for patients with chronic kidney disease.

While new medicines like Forxiga advance the standard of care, we are also committed to the prevention and early detection of this often debilitating and life-threatening disease.”

The DAPA-CKD Phase III trial demonstrated that Forxiga, on top of standard-of-care (SoC) treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the relative risk of worsening of renal function, onset of end-stage kidney disease (ESKD), or risk of cardiovascular (CV) or renal death by 39%, the primary composite endpoint, compared to placebo (absolute risk reduction [ARR]=5.3%, p<0.0001) in patients with CKD Stages 2-4 and elevated urinary albumin excretion. 

Forxiga also significantly reduced the relative risk of death from any cause by 31% (ARR=2.1%, p=0.0035) compared to placebo.

The safety and tolerability of Forxiga were consistent with the well-established safety profile of the medicine.

Forxiga (known as Farxiga in the US) was recently approved in the US and the European Union for the treatment of CKD in adults with and without T2D and is currently under review in several other countries around the world. 

Forxiga is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with T2D and as an oral adjunct treatment to insulin for adults with type-1 diabetes (T1D).

It is also approved for the treatment of symptomatic chronic heart failure (HF) with reduced ejection fraction (HFrEF) in adults with and without T2D. 

In 2013, AstraZeneca K.K. (AZKK), a subsidiary in Japan of AstraZeneca, entered into an agreement with Ono Pharmaceutical Co., Ltd. (Ono) for Forxiga. Based on this agreement, Ono is responsible for distribution and marketing of Forxiga in Japan and has been co-promoting it with AZKK for the treatment of T2D, T1D and chronic HF. Both Companies will co-promote for the treatment of CKD. 

CKD
CKD is a serious, progressive condition defined by decreased kidney function (shown by reduced estimated glomerular filtration rate (eGFR) or markers of kidney damage, or both, for at least three months).

The most common causes of CKD are diabetes, hypertension and glomerulonephritis.

CKD is associated with significant patient morbidity and an increased risk of CV events, such as HF and premature death. In its most severe form, known as ESKD, kidney damage and deterioration of kidney function have progressed to the point where dialysis or kidney transplantation are required.

The majority of patients with CKD will die from CV causes before reaching ESKD.

Currently in Japan, more than 13 million people are living with CKD.

DAPA-CKD
DAPA-CKD was an international, multi-centre, randomised, double-blinded Phase III trial in 4,304 patients designed to evaluate the efficacy of Forxiga 10mg, compared with placebo, in patients with CKD Stage 2-4 and elevated urinary albumin excretion, with and without T2D.

Forxiga was given once daily in addition to SoC. The primary composite endpoint was worsening of renal function or risk of death (defined as a composite of an eGFR decline ≥50%, onset of ESKD or death from CV or renal cause).

The secondary endpoints included the time to first occurrence of the renal composite (sustained ≥50% eGFR decline, ESKD or renal death), the composite of CV death or hospitalisation for HF (hHF), and death from any cause.

The trial was conducted in 21 countries.

Detailed results from the trial were published in The New England Journal of Medicine.

Forxiga
Forxiga (dapagliflozin) is a first-in-class, oral, once-daily SGLT2 inhibitor. Research has shown Forxiga’s efficacy in preventing and delaying cardiorenal disease, while also protecting the organs – important findings given the underlying links between the heart, kidneys and pancreas.

Damage to one of these organs can cause the other organs to fail, contributing to leading causes of death worldwide, including T2D, HF and CKD.

Forxiga is approved as an adjunct to diet and exercise to improve glycaemic control in adults with T2D and in T2D to reduce the risk of hHF or CV death when added to SoC based on the findings of the DECLARE-TIMI 58 Phase III CV outcomes trial.

Forxiga is also approved for the treatment of HFrEF and the treatment of CKD based on the findings of the DAPA-HF and DAPA-CKD Phase III trials.

DapaCare is a robust programme of clinical trials to evaluate the potential CV, renal and organ protection benefits of Forxiga.

It includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000 patients, as well as more than 2.5 million patient-years’ experience. 

Forxiga is currently being tested in the DELIVER Phase III trial to evaluate its efficacy in the treatment of patients with HF with preserved ejection fraction with or without T2D and in the DAPA-MI Phase III trial – a first of its kind, indication-seeking registry-based randomised controlled trial in patients without T2D following an acute myocardial infarction (MI) or heart attack.

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/forxiga-approved-in-japan-for-ckd.html

GSK receives FDA approval for JEMPERLI for adult patients with solid tumours

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GSK receives FDA approval for JEMPERLI for adult patients with solid tumours

August 17, 2021: “GlaxoSmithKline announced the US FDA approved a new indication for JEMPERLI (dostarlimab-gxly), a programmed cell death receptor-1 (PD-1) blocking antibody, for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.

This indication received accelerated approval based on tumour response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “For patients with tumours expressing the dMMR biomarker, there continues to be a significant need for new and effective treatments. I’m excited about GSK’s second oncology FDA approval this year, and the new treatment option it provides for these patients.”

Mismatch repair-deficient tumours contain abnormalities that affect the proper repair of DNA when copied in a cell.

In the US, prevalence of dMMR across patients with solid tumours has been estimated at 14%.

Mismatch repair-deficient status is a biomarker that has been shown to predict response to immune checkpoint blockade with PD-1 therapy.

Tumours with this biomarker are most commonly found in endometrial, colorectal and other gastrointestinal cancers, but may also be found in other solid tumours.

Dr Jubilee Brown, Professor and Division Director of Gynecologic Oncology at Atrium Health Levine Cancer Institute, and investigator on the GARNET study, said: “Dostarlimab is an important new treatment option for patients with mismatch repair-deficient recurrent or advanced solid cancers who have progressed and have no alternative options.

As we saw in the GARNET trial, of those patients who respond to treatment with dostarlimab, nearly all continued to respond for six months or longer.”

This new indication follows an FDA priority review of the Biologics License Application and is based on the collective results from the dMMR endometrial cancer cohort A1 and the dMMR solid-tumour (non-endometrial cancer) cohort F of the ongoing GARNET trial.

The GARNET trial is a multicentre, non-randomised, multiple parallel-cohort, open-label study. Cohort F included patients with dMMR recurrent or advanced non-endometrial cancers, with the highest prevalence in colorectal, small intestine and stomach cancers.

The major efficacy outcomes of the GARNET trial are objective response rate (ORR) and duration of response (DoR), as assessed against RECIST v 1.1 by blinded independent central review.

Results in all dMMR solid tumours, including endometrial and non-endometrial solid tumours (n=209), demonstrated an ORR of 41.6% (95% CI; 34.9-48.6) with a complete response rate of 9.1% and a partial response rate of 32.5%.

The median DoR was 34.7 months (range 2.6-35.8+) with 95.4% of patients maintaining a response for six months or longer. In the dMMR solid tumour non-endometrial cancer cohort (n=106), results demonstrated an ORR of 38.7% (95% CI; 29.4-48.6).

Patients received 500 mg of dostarlimab as an intravenous infusion once every three weeks for four doses, followed by 1,000 mg once every six weeks until disease progression or unacceptable toxicity.

Among the 267 patients with recurrent or advanced dMMR solid tumours who were evaluable for safety, the most commonly reported adverse reactions (≥20%) were fatigue/asthenia (42%), anaemia (30%), diarrhoea (25%) and nausea (22%).

The most common Grade 3 or 4 adverse reactions (≥2%) were anaemia, fatigue/asthenia, increased transaminases, sepsis and acute kidney injury.

Grade 3 or 4 laboratory abnormalities (≥2%) included decreased lymphocytes, decreased sodium, increased alkaline phosphatase and decreased albumin.

In April 2021, the FDA granted accelerated approval for dostarlimab for the treatment of adult patients with dMMR recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that have progressed on or following prior treatment with a platinum-containing regimen. This approval was based on data from cohort A1, which included 71 patients with dMMR endometrial cancer.

With the dMMR solid-tumour approval, the US prescribing information for this indication includes efficacy data for an additional 32 patients in the endometrial cancer cohort A1 (n=103).

The additional results for this cohort show an ORR of 44.7% (95% CI; 34.9-54.8) with a DoR range of 2.6-35.8+ months. The results of the endometrial cancer cohort of the GARNET trial represent the largest dataset to date evaluating an anti-PD-1 as monotherapy treatment for women with endometrial cancer.

As we work to expand our oncology pipeline and portfolio of cancer treatments, GSK is also studying dostarlimab in earlier lines of treatment for endometrial cancer and in combination with other therapeutic agents for patients with advanced/metastatic cancers beyond endometrial cancer.

About GARNET
The ongoing phase I GARNET trial is evaluating dostarlimab as monotherapy in patients with advanced solid tumours.

Part 2B of the study includes five expansion cohorts: dMMR/MSI-H endometrial cancer (cohort A1), mismatch repair proficient/microsatellite stable (MMRp/MSS) endometrial cancer (cohort A2), non-small cell lung cancer (cohort E), dMMR/MSI-H non-endometrial or POLE-mut solid tumour basket cohort (cohort F), and platinum-resistant ovarian cancer without BRCA mutations (cohort G).

Patients enrolled in cohort A1 needed to have progressed on or following prior treatment with a platinum-containing regimen, whereas, patients enrolled in cohort F needed to have progressed following systemic therapy and had no satisfactory alternative treatment options; patients with colorectal cancer must have had progressive disease after, or have been intolerant to, a fluoropyrimidine, oxaliplatin, and irinotecan.”

https://www.gsk.com/en-gb/media/press-releases/gsk-receives-fda-accelerated-approval-for-jemperli-dostarlimab-gxly-for-adult-patients-with-mismatch-repair-deficient-dmmr-recurrent-or-advanced-solid-tumours/

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