Merck's ENFLONSIA Expands Indication to Include Children Under Two Years Old at Increased Risk for Severe RSV Disease

Merck, known as MSD outside of the US and Canada, announced that the FDA has accepted a supplemental Biologics License Application for ENFLONSIA (clesrovimab-cfor) to expand its indication to include children under two years old at increased risk for severe RSV disease through their second RSV season.

The application is supported by data from the Phase 3 SMART trial, which demonstrated that ENFLONSIA reduced the risk of RSV LRTD in high-risk infants during their first RSV season. The FDA has set a PDUFA target action date of March 22, 2027.

The European Medicines Agency also accepted an application for ENFLONSIA to expand its indication to include children under two years old at increased risk for severe RSV disease through their second RSV season based on the same data from the Phase 3 SMART trial.