MedPage Today September 27, 2024
— The agency has issued a revised fact sheet for healthcare providers
The FDA has determined that the monoclonal antibody pemivibart (Pemgarda) is likely to be effective against currently circulating SARS-CoV-2 variants, including KP.3.1.1 and LB.1.
“Based on current CDC Nowcast estimates and variant spike receptor binding domain similarity to tested variants, FDA anticipates Pemgarda will retain activity against the currently circulating variants in the U.S.,” the agency said in a press release.
This is welcome news for patients at risk for severe COVID-19, such as those with immunocompromising conditions. Pemivibart remains the only available monoclonal antibody for the prevention of COVID-19 in this population.
In late August, the FDA had revised the emergency use authorization (EUA) for pemivibart, adding...