Merck 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
Business Wire•13/11/2026•06:40 ET
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Key Highlights
- ➤Merck (MRK) receives positive EU CHMP opinion expanding ENFLONSIA to vulnerable children through their second RSV season
- ➤European Commission decision on the expanded marketing authorization is expected within two months
- ➤FDA accepted ENFLONSIA’s supplemental application, with a March 22, 2027 PDUFA target date
- ➤ENFLONSIA is approved in more than 55 countries for infants entering their first RSV season
Expert Statements
Macaya Douoguih, Vice President and Therapeutic Area Head, Global Clinical Development, Merck Research Laboratories
“For some children, the risk of severe RSV does not end after their first RSV season and they remain at increased risk for serious cases of RSV-related bronchiolitis or pneumonia that can require hospitalization”
Macaya Douoguih, Vice President and Therapeutic Area Head, Global Clinical Development, Merck Research Laboratories
“The positive CHMP opinion is an important step toward bringing ENFLONSIA to children in the European Union who remain at increased risk, helping protect them during their second RSV season”
Merck 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
Some children up to 24 months of age remain vulnerable to severe RSV in their second RSV season – underscoring the importance of preventive options for this at-risk population
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