The FDA has approved Merck’s Enflonsia, a monoclonal antibody designed to prevent respiratory syncytial virus lower respiratory tract disease in newborns and infants.
The approval is based on data from a phase 2b/3 trial, which showed a 60.5% reduction in RSV-associated medically attended lower respiratory infections compared to placebo, according to a June 9 news release from the drugmaker.
The treatment also reduced RSV-associated hospitalizations by 84.3%. Enflonsia is administered as a single 105 mg dose, regardless of infant weight, and is designed to provide protection through a typical five-month RSV season.
The CDC’s Advisory Committee on Immunization Practices is expected to review use recommendations later this month, with distribution expected to begin before the 2025-2026 RSV season.
