EU CHMP backs Merck’s ENFLONSIA expansion to children up to 24 months
Merck received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending approval of an expanded indication for ENFLONSIA (clesrovimab) to prevent RSV lower‑respiratory‑tract disease in high‑risk children up to 24 months. The recommendation will be reviewed by the European Commission, with a final decision expected within two months. The CHMP opinion is supported by the Phase 3 SMART trial, which enrolled 502 participants receiving ENFLONSIA in the first RSV season and 276 receiving an additional dose in the second season.
Why it matters
The expanded indication would allow Merck to market ENFLONSIA to a larger pediatric population in the EU, potentially increasing sales and strengthening its RSV portfolio (the company notes the broader market opportunity in its press release). The pending Commission decision creates short‑term price pressure, as reflected by a 0.65% rise in MRK shares to $147.90.
Key facts
- 1The CHMP adopted a positive opinion recommending approval of ENFLONSIA for children up to 24 months at increased risk of severe RSV disease through their second season. merck.com
- 2The European Commission will review the recommendation and is expected to decide within two months. merck.com
- 3The Phase 3 SMART trial enrolled 502 participants receiving ENFLONSIA in RSV season 1 and 276 eligible children receiving an additional 210 mg dose in RSV season 2. merck.com
- 4ENFLONSIA is already approved in more than 55 countries for infants during their first RSV season. merck.com
- 5Merck’s stock rose 0.65% to $147.90 after the EU opinion was announced. blockonomi.com
Summary written by AlphAI AI Desk from 7 of 7 sources. Not investment advice. Figures are as stated by the linked sources.