U.S. FDA approves COVID preventive Pemgarda for immunocompromised persons

FDA OKs Invivyd's COVID preventive Pemgarda for emergency use The pre-exposure treatment is indicated for adolescents and adults with moderate-to-severe immunocompromising conditions. CIDRAP

The Food and Drug Administration (FDA) on March 22 granted emergency use authorization (EUA) for Invivyd's monoclonal antibody to prevent COVID-19 in immunocompromised patients, which fills a gap following the withdrawal of Evusheld in January 2023.

The monoclonal antibody, called pemivibart (Pemgarda), is authorized for pre-exposure prophylaxis in adolescents and adults with moderate-to-severe immunocompromise, such as solid-organ transplant recipients and those with blood cancers. ...