Pemgarda FDA Approval Status
Last updated by Judith Stewart, BPharm on March 24, 2024.
FDA Approved: No (Emergency Use Authorization)
Brand name: Pemgarda
Generic name: pemivibart
Dosage form: Injection
Previous Name: VYD222
Company: Invivyd, Inc.
Treatment for: Pre-Exposure Prophylaxis of COVID-19
Pemgarda (pemivibart) is a SARS-CoV-2 spike protein-directed attachment inhibitor authorized for emergency use for the pre-exposure prophylaxis of COVID-19.
- The U.S. FDA has issued an EUA for the emergency use of the unapproved product Pemgarda (pemivibart) for the pre-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in adults and adolescents (12 years of age and older weighing at least 40 kg) 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 receipt of immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.
- Pemgarda is not FDA-approved for any use, including use for pre-exposure prophylaxis of COVID-19.
- Pemgarda is NOT authorized for use:
- for treatment of COVID-19
- for post-exposure prophylaxis of COVID-19 in individuals who have been exposed to someone infected with SARS-CoV-2. - 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 a recombinant human monoclonal IgG1ʄ antibody that works by targeting the SARS-CoV-2 spike protein receptor binding domain, thereby inhibiting virus attachment to the human ACE2 receptor on host cells.
- 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 authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Pemgarda under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner.
- Pemgarda is administered by intravenous infusion over a minimum of 60 minutes. Repeat doses are administered every three months.
- Warnings and precautions associated with Pemgarda include anaphylaxis, hypersensitivity and infusion-related reactions, risk of cross-hypersensitivity with COVID-19 vaccines, and an increased risk for COVID-19 due to SARS-CoV-2 viral variants not neutralized by Pemgarda.
- 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.
Development timeline for Pemgarda
Further information
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