emergency use authorization Archives - Medical Design Sourcing

FDA authorization of vilobelimab signals new opportunities for drug developers in inflammatory diseases

The FDA has granted InflaRx (Nasdaq:IFRX) emergency use authorization (EUA) for the monoclonal antibody Gohibic (vilobelimab) to treat critically-ill COVID-19 patients. The company’s shares were up yesterday almost 84% to $3.77. Today, its shares jumped an additional 62% to $6.10.

The EUA represents a significant advance for the Jena, Germany–based company, which on March 31, 2022, encountered a setback related to the antibody. At that time, the company announced that vilobelimab failed a topline readout for critically ill intubated patients suffering from COVID-induced pneumonia in the phase 2/3 PANAMO study. Later, however, InflaRx reported in a predefined analysis without site-stratification that vilobelimab significantly decreased all-cause mortality at 28 days. While the initial protocol did not require site-stratification, the company amended the protocol based on regulators’ recommendations.

Regulatory nod for vilobelimab could spark new developments …

Pfizer and BioNTech secure FDA nod for omicron-adapted COVID-19 booster for kids under 5

COVID-19 vaccine developers Pfizer (NYSE:PFE) and its partner BioNTech (Nasdaq:BNTX) have won emergency use authorization (EUA) for a single booster dose of their omicron BA.4/BA.5-adapted bivalent COVID-19 booster for kids between 6 months and 4 years of age.

The booster can be administered at least two months after completing the primary vaccination series with three doses of the original Pfizer-BioNTech COVID-19 vaccine. Additionally, FDA has authorized the bivalent vaccine for use as the third dose in a primary series for the same age group. The agency, however, has not yet authorized a fourth booster dose.

Trial data Supports bivalent vaccine safety and efficacy

The EUA is based on data from substudies within the companies’ Phase 1/2/3 trial (NCT05543616) evaluating the safety, tolerability and immunogenicity of a fourth bivalent vaccine dose in 300 children aged 6 months to 4 years. A subset of 60 study participants within the same age group demonst…

FDA allows pharmacists to prescribe Paxlovid

FDA has revised the Emergency Use Authorization (EUA) for Pfizer’s (NYSE:PFE) Paxlovid (nirmatrelvir and ritonavir) to allow state-licensed pharmacists to prescribe the drug to some patients with a high risk of COVID-19.

While the move allows pharmacists to prescribe Paxlovid, it has limits. It instructs the professionals to refer patients to a physician if there is insufficient information to assess patients’ renal and hepatic function and the potential for a drug interaction. In addition, the updated EUA requires a physician to potentially modify the prescription of other medications to avoid an adverse drug interaction. As a result, pharmacists will not be able to prescribe the drug to patients with a potential drug interaction risk who are not able to be monitored.

The FDA rules also require pharmacists to confirm that Paxlovid is an appropriate treatment based on a Fact Sheet for Healthcare Providers.

To verify eligibility, pharmacists must ensure t…

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…

Pfizer and BioNTech file for EUA for COVID-19 vaccine booster in kids 5 to 11

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application with the FDA for emergency use authorization (EUA) for a 10-µg booster dose of their BNT162b2 COVID-19 vaccine in children aged 5 to 11.

The companies included data in the application from a Phase 2/3 study that tested a booster dose in children between 5 and 11, roughly six months after completion of a primary series.

The Pfizer-BioNTech vaccine remains one of the most popular COVID-19 vaccines globally.

FDA authorized an EUA for a primary series of the BNT162b2 vaccine for children 5 to 11 in October 2021.

Pfizer and BioNTech also intend to seek authorization from the European Medicines Agency (EMA) and other regulatory agencies for a booster dose soon.

In the U.S., CDC recently estimated that roughly three-quarters of children had detectable antibodies to SARS-CoV-2, thanks in part to the rapid spread of the omicron variant.

More than half of U.S. adult…

Pfizer and BioNTech seeking FDA authorization of fourth COVID-19 vaccine dose for older adults

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application to the FDA for Emergency Use Authorization (EUA) for an additional COVID-19 vaccine booster dose in adults 65 years of age and older.

The two companies submitted two real-world data sets from Israel while the omicron variant was widespread.

Pfizer notes that an additional dose of the BNT162b2 vaccine enhanced protection against infections and severe illness.

One dataset involved patient records from the Israeli Ministry of Health involving more than 1.1 million adults at least 60 years old with no known prior COVID-19 infection eligible for a fourth dose booster. That data suggested that individuals receiving an additional dose were half as likely to be infected and had one-fourth the risk of contracting severe illness than those who had received a single booster.

The companies also submitted data from an ongoing, open-label, non-randomized study focused on healthcare w…

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…

GSK and Vir upbeat about efficacy of sotrovimab against Omicron

GlaxoSmithKline (LON:GSK) and its partner Vir Biotechnology (NSDQ:VIR) have announced that their COVID-19 drug sotrovimab continues to offer protection against the mutations in the spike protein of the Omicron SARS-CoV-2 variant.

In March, the two companies received emergency use authorization (EUA) for the drug. The EUA specifically covers the treatment of mild-to-moderate COVID-19 in high-risk adults and children.

Drawing on preclinical research, the two companies suggest that at least one dose of sotrovimab would protect against Omicron, which WHO has categorized as a variant of concern. The preclinical research involved pseudo-virus testing, including 37 mutations in the Omicron variant spike protein.

Formerly known as VIR-7831, sotrovimab is a monoclonal antibody.

The antibody is the first with “preclinical data demonstrating activity against all tested SARS-CoV-2 variants of concern and interest to date, including Omicron, as well as the sti…

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…