FDA Grants EUA To mAb For COVID Prevention In Immunocompromised Patients

FDA announced Friday (March 22) it has issued emergency use authorization (EUA) to a monoclonal antibody (mAb) product for pre-exposure prophylactic prevention of COVID-19 in some immunocompromised individuals, making it the only mAb authorized to reduce COVID transmission in the United States. Pemgarda (pemvibart), developed by pharmaceutical company Invivyd, is based on a platform technology the company plans to use to address rapid emergence of new COVID variants. The product is authorized for adults and adolescents who are moderately to...