Merck’s Biologics License Application for clesrovimab accepted by FDA

Merck (MRK) announced the FDA has accepted the Biologics License Application, or BLA, for clesrovimab, the company’s investigational prophylactic long-acting monoclonal antibody designed to protect infants from respiratory syncytial virus – RSV – disease during their first RSV season. The FDA has set a Prescription Drug User Fee Act or target action date of June 10, 2025. The application is supported by results from the pivotal Phase 2b/3 CLEVER trial evaluating a single dose of clesrovimab administered to healthy preterm and full-term infants, and interim results from the ongoing Phase 3 SMART trial evaluating the safety and efficacy of clesrovimab versus palivizumab in infants and children at increased risk for severe RSV disease. Data from these trials were presented in October 2024. If approved, Merck anticipates that clesrovimab would be available for ordering by physicians and healthcare administrators by July 2025, with shipments to arrive in time for the 2025 RSV season.