Merck Receives FDA Approval for Clesrovimab for RSV Prevention in Infants

Merck today announced that the FDA has approved clesrovimab for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants entering their first RSV season. Clesrovimab is a long-acting monoclonal antibody that targets the RSV fusion protein. In the Phase 3 MELODY trial, clesrovimab demonstrated a statistically significant reduction in RSV-associated lower respiratory tract disease compared to placebo. The single-dose intramuscular injection provides protection throughout the RSV season. This approval provides a new option for RSV prevention in infants alongside existing prophylaxis options.