US pharmaceutical company Merck & Co Inc (NYSE:MRK), known as MSD outside the US and Canada, announced on Friday that the European Commission 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.

This approval covers all 27 European Union member states, as well as Iceland, Liechtenstein, and Norway, with timing for availability in each country depending on reimbursement and other procedures.

ENFLONSIA is a long-acting monoclonal antibody designed to provide protection for approximately five months using a non-weight-based dosing regimen.

The European Commission approval is supported by data from the Phase 2b/3 CLEVER trial and interim results from the Phase 3 SMART trial, which evaluated safety, efficacy, and pharmacokinetics in infants, including comparisons with palivizumab.

ENFLONSIA is already approved in the United States, Canada, Switzerland, and several other countries for use in infants during their first RSV season, with additional regulatory filings ongoing globally.