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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

MRK
  • Merck's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending expanded approval for ENFLONSIA (clesrovimab) to prevent RSV lower respiratory tract disease in children up to 24 months at high risk through their second RSV season.
  • The CHMP recommendation is now under review by the European Commission for marketing authorization in the EU, Iceland, Liechtenstein, & Norway, with a final decision expected within two months.
  • ENFLONSIA was previously approved in the U.S. in June 2025 & in the EU in April 2026 for infants during their first RSV season.
  • The FDA accepted a supplemental Biologics License Application to expand the U.S. indication for children under two years at increased risk, setting a target action date of March 22, 2027.
  • The expanded indication targets children with chronic lung disease, congenital heart disease, or early/moderate preterm birth who remain vulnerable to severe RSV beyond their first season.
  • The CHMP opinion is supported by Phase 3 SMART trial results published in September 2025 & July 2026, showing efficacy & safety over two RSV seasons.
  • ENFLONSIA is currently approved in over 55 countries for the first RSV season, with regulatory filings underway for global expansion of the new indication.
  • The drug is administered as a single fixed dose (105 mg for season 1, 210 mg for season 2) without weight-based calculations & provides protection for up to 5 months.
  • Common adverse reactions include injection-site erythema (4.5%), injection-site swelling (3.2%), & rash (2.3%).
  • ENFLONSIA may interfere with rapid RSV antigen tests, requiring confirmation via RT-PCR if clinical symptoms persist despite negative rapid results.