European Commission approves Merck’s ENFLONSIA for RSV disease in infants

Merck (MRK) announced that the European Commission has approved ENFLONSIA for the prevention of respiratory syncytial virus lower respiratory tract disease in neonates and infants during their first RSV season. ENFLONSIA is contraindicated for infants with hypersensitivity to the active substance or any of its excipients. ENFLONSIA is a preventive, long-acting monoclonal antibody 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 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.