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FDA has accepted the sBLA of Enflonsia to prevent RSV lower respiratory tract disease (LRTD) in children (<2yrs.) at increased risk for severe RSV disease through their second RSV season (PDUFA: Mar 22, 2027); application is also under EMA review
Submissions were supported by P-III (SMART/MK-1654-007) trial assessing Enflonsia in infants & children over two RSV seasons, results of which are published in The NEJM (interim RSV season 1 results) & JAMA Pediatrics (full results)
Enflonsia was approved by the FDA (2025) & the EC (2026) to prevent RSV LRTD in infants during their first RSV season. It does not require weight-based dosing
Ref: Businesswire | Image: Merck | Press Release
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