Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab (MK-1654), the company’s investigational prophylactic long-acting monoclonal antibody. This antibody is designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season, a critical period for infant health.
Clesrovimab (MK-1654): An Extended Half-Life Monoclonal Antibody for RSV Prevention
Clesrovimab (MK-1654) is an investigational, extended half-life monoclonal antibody (mAb) developed for passive immunization to prevent RSV disease. The application’s acceptance is supported by the positive results from the pivotal Phase Ⅱb/Ⅲ CLEVER trial (MK-1654-004), which demonstrated clesrovimab’s efficacy in reducing RSV-associated hospitalizations by more than 84% (secondary endpoint) and RSV-associated lower respiratory infection hospitalizations by 90% (tertiary endpoint) through five months.
Implications for Infant Health and RSV Prevention
The acceptance of the BLA for clesrovimab by the FDA marks a significant step forward in the development of a potential new option for preventing RSV disease in infants. If approved, clesrovimab could provide a much-needed prophylactic measure to protect infants during their first RSV season, potentially reducing the burden of RSV-related hospitalizations and improving health outcomes for this vulnerable population.-Fineline Info & Tech
