FDA Issues an Emergency Use Authorization for Pemgarda (pemivibart) for the Pre-Exposure Prophylaxis of COVID-19
March 22, 2024 -- Today, the FDA issued an emergency use authorization (EUA) for Pemgarda (pemivibart) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kilograms [about 88 pounds]).
Pemgarda is authorized for individuals:
- who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2;
- and who have moderate-to-severe immune compromise due to a medical condition or due to taking immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.
Pemgarda was granted emergency use authorization based on positive immunobridging data and on safety data from the CANOPY clinical trial along with ongoing in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1.
Pemgarda is not FDA-approved for any use, including use for pre-exposure prophylaxis of COVID-19.
Pemgarda may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants who are licensed or authorized under State law to prescribe drugs.
Pemgarda is administered by intravenous infusion over a minimum of 60 minutes. Repeat doses are administered every three months.
Common adverse reactions in people with moderate-to-severe immune compromise treated with Pemgarda include systemic and local infusion-related or hypersensitivity reactions, upper respiratory tract infection, viral infection, influenza-like illness, fatigue, headache, and nausea.
For more information about Pemgarda and its authorization, please see the resources available on the FDA’s Emergency Use Authorization webpage.
Posted March 2024
Further Support and Information on COVID-19
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