Merck & Co’s clesrovimab BLA accepted by FDA

17 December 2024

The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab (MK-1654), Merck & Co’s (NYSE: MRK) prophylactic long-acting monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season.

A Prescription Drug User Fee Act, or target action, date of June 10, 2025 has been set by the FDA. 

Paula Annunziato, senior vice president, infectious diseases and vaccines, global clinical development, Merck Research Laboratories, said: “Despite recent advances in RSV prevention, unmet needs remain for additional effective interventions to help protect infants and continue to help address the burden RSV places on families and the healthcare system. 

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