Pemgarda FDA Approval Status
Last updated by Judith Stewart, BPharm on Aug 26, 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 emergency use authorization (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 is authorized for use only when the combined national frequency of variants with substantially reduced susceptibility to Pemgarda is less than or equal to 90%, based on available information including variant susceptibility to Pemgarda and national variant frequencies.
- 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. As of August 2024, the most frequently reported SARS-CoV-2 viral variants circulating in the US were KP.3 (17%) and KP.3.1.1 (37%). Based on the data available at that time, it is understood that Pemgarda is likely to retain adequate neutralization activity against KP.3, but KP.3.1.1 may have substantially reduced susceptibility to Pemgarda.
- 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 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.
- Pemgarda carries a Boxed Warning for anaphylaxis, which may be life-threatening. 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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