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…
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…
Pfizer officially asks FDA to expand COVID-19 vaccine access to younger kids
Pfizer (NYSE:PFE) and BioNTech (NSDQ: BNTX) announced today that they submitted a request to the FDA to expand the 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,…
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…
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…
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 nixes EUA for Lilly’s bamlanivimab
On April 16, Lilly announced that it was requesting FDA to revoke the emergency use authorization (EUA) for the monoclonal antibody bamlanivimab (LY-CoV555) when used alone. Hours after, the agency agreed to rescind the EUA on the grounds that bamlanivimab is potentially ineffective against some SARS-CoV-2 variants. Bamlanivimab, however, won’t be disappearing as a COVID-19…