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European Commission approves Enflonsia for infants’ first RSV season as Merck reports new SMART data

Apr 17, 2026

The European Commission approved Enflonsia for prevention of RSV lower respiratory tract disease in infants during their first RSV season. Merck also reported new Phase 3 SMART data showing generally consistent second-season safety in high-risk children under 2 years old.

Merck Reports Positive Second-Season Data for ENFLONSIA in High-Risk Children

Feb 24, 2026

Merck announced positive second RSV season findings from the Phase 3 SMART trial evaluating ENFLONSIA (clesrovimab) in infants and children under 2 years at increased risk for severe RSV disease, showing consistent safety and antibody levels similar to healthy infants.