Invivyd announces submission to FDA of updated analysis of pemivibart

Invivyd (IVVD) announced the submission to the U.S. Food and Drug Administration, FDA, of an updated immunobridging analysis of pemivibart as ongoing support of a potential amendment to the Emergency Use Authorization, EUA, for pemivibart, a half-life extended investigational monoclonal antibody, mAb, to include the treatment of mild-to-moderate symptomatic COVID-19 in certain immunocompromised patients for whom alternative COVID-19 treatment options are not accessible or clinically appropriate. PEMGARDA received an EUA from the FDA in March 2024 for pre-exposure prophylaxis, PrEP, of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise.