Merck (MRK) Receives Positive EU CHMP Opinion to Expand Marketing Authorization for ENFLONSIA® (clesrovimab) to Include Children Up to 24 Months of Age Who Remain Vulnerable to Severe RSV Disease Through Their Second RSV Season

Merck received a positive opinion from the European Medicines Agency's CHMP recommending expanded approval of ENFLONSIA (clesrovimab) to prevent RSV lower respiratory tract disease in children up to 24 months old who remain at risk of severe illness through their second RSV season. The recommendation extends the antibody's existing authorization beyond its current infant indication, covering a broader pediatric population in the EU. The CHMP opinion now moves to the European Commission, whose final decision is the next regulatory milestone to watch. The expansion matters because it widens the addressable patient pool for Merck's RSV antibody franchise in Europe and positions the company to compete for second-season prophylaxis, a segment where durability across two RSV seasons is a key differentiator.