EUA Archives - Medical Design Sourcing

FDA denies EUA for COVID-19 indication of SSRI fluvoxamine

[Fluvoxamine image from Wikipedia]

The infectious disease physician-scientist Dr. David R Boulware filed for emergency use authorization (EUA) of fluvoxamine, an established selective serotonin reuptake inhibitor (SSRI) whose brand name is Luvox.

The FDA has rejected the application, explaining the treatment benefit of the drug was “not persuasive” in the TOGETHER study that was the basis of the EUA application.

The randomized, double-blind study had a composite endpoint consisting of a reduction of emergency room visits due to worsening COVID-19 infection and hospitalization resulting from COVID-19 up to 28 days after randomization.

The study concluded that fluvoxamine reduced COVID-19 hospitalizations by as much as 30%.

Although the study met its primary endpoint, FDA noted that “the results were primarily driven by a reduction in the emergency department visits lasting greater than 6…

FDA authorizes new antibody from Lilly that holds up to omicron

FDA has authorized bebtelovimab, a monoclonal antibody from Eli Lilly and Company (NYSE:LLY), for certain high-risk patients with COVID-19.

The emergency use authorization (EUA) for the antibody covers the treatment of mild-to-moderate COVID-19 in individuals at least 12 years of age who weigh at least 40 kg (about 88 pounds). The EUA is constrained to individuals who are not good candidates for existing approved or authorized alternative COVID-19 therapies.

The authorization covers a single 175-mg intravenous dose of bebtelovimab is 175 mg administered over at least 30 seconds.

Lilly began developing bebtelovimab early in 2021 and confirmed its potency against omicron in pseudovirus and authentic virus testing.

Dr. Daniel Skovronsky

The broadly neutralizing antibody “could be used to fight a highly mutated variant, should one emerge,” said Dr. Daniel Skovronsky, Lill…

FDA authorizes COVID-19 antibody cocktail for younger children

The FDA will allow the use of Lilly’s (NYSE:LLY) bamlanivimab and etesevimab antibodies for younger pediatric patients, including newborns.

The revised expanded emergency use authorization (EUA) specifically includes children with mild-to-moderate COVID-19 who face a high risk of disease progression.

The EUA previously covered children at least 12 years of age who weigh at least 40 kilograms.

The FDA will now allow the use of the antibody cocktail as post-exposure prophylaxis (PEP) to prevent COVID-19 in all pediatric patients with a high risk of progressing to severe COVID-19.

Bamlanivimab and etesevimab image courtesy of Lilly.

The expanded authorization is not intended to provide an alternative to vaccination, said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “Vaccines remain our best tool in the fight against the virus, an…

Pfizer officially asks FDA to expand COVID-19 vaccine access to younger kids

Image courtesy of Wikipedia

Pfizer (NYSE:PFE) and BioNTech (NSDQ: BNTX) announced today that they submitted a request to the FDA to expand authorization of their COVID-19 vaccine to younger children.

Expanded FDA emergency use authorization would allow for the use of the COVID-19 vaccine candidate, which has full FDA approval for people 16 years of age and older, in children aged 5 to 11. It received EUA for adolescents aged 12 to 15 in May.

Last month, the companies announced their plan to formally seek FDA emergency authorization in the coming weeks for the use of their Comirnaty (BNT162b2) vaccine in children 5 to 11, following the submission of initial Phase 2/3 trial data to FDA. Today, in an announcement on Twitter, Pfizer and BioNTech confirmed the official submission of their request for EUA.

With new cases in children in the U.S. continuing to be at a high level, this submission is an …

FDA rejects EUA for Humanigen’s monoclonal antibody for COVID-19

FDA determined it couldn’t conclude that the benefits of lenzilumab from Humanigen (NSDQ:HGEN) outweigh the risks for patients hospitalized with COVID-19.

Lenzilumab is the company’s lead product candidate.

The drug works by neutralizing granulocyte-macrophage colony-stimulating factor (GM-CSF), which is implicated in the so-called cytokine storm.

The drug is the subject of 16 clinical trials spanning a range of diseases.

The Burlingame, California–based company had submitted EUA paperwork to the agency in May. Included in the filing were data from the LIVE-AIR Phase 3 clinical trial that evaluated the drug’s role in improving survival without ventilation (SWOV) in newly hospitalized COVID-19 patients.

The company’s shares dropped 47.25% apiece to $7.97 following the announcement.

Analysts at H.C. Wainwright wrote in a brief note that the stock drop was an “overreaction,” but reduced their price target for the compa…

Pfizer to seek to expand COVID-19 vaccine EUA to children aged 5 to 11

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) aim to expand the U.S. emergency use authorization (EUA) for their COVID-19 vaccine to include children aged five to 11.

The companies plan on filing paperwork for the expanded EUA over the coming months. “We are planning for emergency use authorization submission for [children aged five to 11] in September or October of this year, and the [two-to-five-year-old] group to follow soon thereafter,” Alejandra Gurtman, MD, Pfizer’s vice president of vaccine clinical research and development, said during a virtual symposium.

FDA has already authorized the vaccine for people 12 and older.

Pfizer’s Phase 1/2/3 study testing vaccine safety and efficacy in children has enrolled approximately 4,500 participants aged six months to 11 years old. Some 90 clinical trial sites in the U.S., Poland, Spain and Finland are taking part in the trial.

The Phase 1/2/3 trial involving children aged six months to 1…

FDA could decline new COVID-19 vaccine EUA requests

Healthcare workers have administered almost 288 million doses of COVID-19 vaccines in the U.S., which now has more than enough vaccine for the present demand.

Against that backdrop, FDA has released updated emergency use authorization (EUA) guidelines for COVID-19 vaccines that state the agency could decline some future EUA requests. “For the remainder of the current pandemic, FDA may decline to review and process further EUA requests other than those for vaccines whose developers have engaged in an ongoing manner with the Agency,” the guidelines explain.

In its most recent guidance, the FDA also stresses the need for EUA vaccine candidates to undergo rigorous product quality review, including scrutiny of manufacturing and clinical trials.

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have already begun filing a Biologics License Application for full FDA approval for their COVID-19 vaccine. Moderna (NSDQ:MRNA) is also pursuing full approval. …