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European Commission Approves Merck’s ENFLONSIA™ (clesrovimab) for the Prevention of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease in Infants During Their First RSV Season
RAHWAY, N.J., April 17, 2026--Merck press release announcing European Commission approval of ENFLONSIA
About this update from Merck & Company, Inc.
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":217,"url":"https://media.zenfs.com/en/business-wire.com/5b1de304f4547737fa93dd01ab1184a7"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/7EhFM_EUL80obMXY69vjaw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTQzNA--/https://media.zenfs.com/en/business-wire.com/5b1de304f4547737fa93dd01ab1184a7","width":480,"height":217}},"lazy":false},{"type":"text","content":"ENFLONSIA is the first and only RSV preventive option in the European Union for administration to infants without the need for weight-based dosing","length":146,"tagName":"p","attribs":{}},{"type":"text","content":"RAHWAY, N.J., April 17, 2026--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the European Commission (EC) has approved ENFLONSIA™ (clesrovimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants during their first RSV season. ENFLONSIA is contraindicated for infants with hypersensitivity to the active substance or any of its excipients.","length":474,"tagName":"p"},{"type":"text","content":"ENFLONSIA is a preventive, long-acting monoclonal antibody (mAb) designed to provide direct, rapid and durable protection through 5 months, a typical RSV season, with non-weight-based dosing. The EC approval authorizes the marketing of ENFLONSIA in all 27 European Union (EU) member states, as well as Iceland, Liechtenstein and Norway. The timing for availability of ENFLONSIA in individual countries will vary by country and depend on multiple factors, including the completion of reimbursement procedures.","length":508,"tagName":"p"},{"type":"text","content":""RSV can progress to severe conditions like bronchiolitis and pneumonia in both healthy and at-risk infants and is among the leading causes of infant hospitalization globally," said Dr. Paolo Manzoni, Head of Maternal–Infant Medicine, University of Torino Hospital Degli Infermi, Ponderano, Italy, and an investigator for the SMART clinical trial. "The approval of ENFLONSIA in Europe represents an important public health achievement. Backed by strong clinical data from the CLEVER and SMART trials showing significant reductions in RSV disease in...