FDA Limits Use of Invivyd’s COVID-19 Prophylactic as New Variants Dominate

Emergency Use Authorization (EUA):
The FDA has granted an EUA for Invivyd's Pemgarda (pemivibart) for pre-exposure prophylaxis (PrEP) of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) with moderate-to-severe immune compromise due to certain medical conditions or receipt of immunosuppressive medications or treatments.

Limitations of Authorized Use:
Pemgarda is not authorized for the treatment of COVID-19 or for post-exposure prophylaxis in individuals who have been exposed to someone infected with SARS-CoV-2. It is also not effective against certain SARS-CoV-2 variants, such as KP.3.1.1, which may have substantially reduced susceptibility to Pemgarda.

Target Population:
The EUA specifically targets individuals who are not currently infected with SARS-CoV-2 and have not had a recent exposure to an individual infected with SARS-CoV-2, and who have moderate-to-severe immune compromise due to medical conditions or treatments that make them unlikely to mount an adequate immune response to COVID-19 vaccination.

Mechanism of Action:
Pemgarda is a half-life extended monoclonal antibody (mAb) that demonstrates in vitro neutralization activity against major SARS-CoV-2 variants, including JN.1.

Commercial Availability:
Invivyd announced that Pemgarda is set to hit the market "imminently," with initial supply already packaged and ready for distribution.

Financial Status:
Invivyd had $200.6 million in cash and cash equivalents as of December 31, 2023, and raised an additional $40.5 million in February 2024 to support the launch of Pemgarda.