Reducing RSV-related hospitalization rates by more than 80%, FDA accepts Merck's long-acting antibody therapy marketing application

Merck (MSD) announced today that the U.S. FDA has accepted the company's biologics license application (BLA) for the investigational preventive long-acting monoclonal antibody clesrovimab (MK-1654), which is designed to protect infants from RSV disease during their first respiratory syncytial virus (RSV) season. The FDA is scheduled to complete the review by June 10, 2025. Clesrovimab is an extended half-life monoclonal antibody under investigation for the prevention of RSV disease as a passive immunization method.

The application is based on the results of the pivotal Phase 2b/3 clinical trial CLEVER, a randomized, placebo-controlled trial evaluating the effect of a single dose of clesrovimab in healthy premature and full-term infants; and interim results of the ongoing Phase 3 clinical trial SMART, which evaluates the safety and efficacy of clesrovimab compared with palivizumab in high-risk infants and children. Data from these trials were presented at the 2024 Infectious Disease Week (IDWeek) conference in October 2024. The data showed that clesrovimab reduced RSV-related hospitalizations and RSV-related lower respiratory tract infection (LRI) hospitalizations by more than 84% and 90%, respectively, within 5 months.

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