FDA Accepts Application to Extend RSV Protection for Vulnerable Infants

The FDA has accepted Merck's supplemental Biologics License Application (sBLA) for Enflonsia (clesrovimab-cfor) to prevent RSV Lower Respiratory Tract Disease (LRTD) in vulnerable children under two years old during their second RSV season. This filing, supported by Phase 3 SMART trial data, aims to expand protection for high-risk infants beyond their initial RSV season, potentially reducing severe illness.