FDA Accepts Supplemental Biologics License Application for Merck's Enflonsia

The US FDA has accepted a supplemental Biologics License Application (sBLA) for Merck's Enflonsia to expand its indication to protect children under two years of age from respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD).

This application is specifically for those who are at increased risk for severe RSV disease through their second RSV season, including those born with chronic lung disease or congenital heart disease.

Enflonsia is the first and only preventive option against RSV LRTD that can be given to infants without requiring weight-based dosing.