- ENFLONSIA™ is a monoclonal antibody for RSV prevention in infants.
- The European Commission's decision is expected by year-end.
- The CHMP recommendation is based on Phase 2b/3 and Phase 3 trials.
Overview
Merck's ENFLONSIA™ (clesrovimab) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the prevention of respiratory syncytial virus (RSV) in infants. This recommendation is now under review by the European Commission, with a decision expected by the end of the year.
Significance
If approved, ENFLONSIA™ will be the first RSV preventive option in Europe that can be administered to infants with a single dose, regardless of weight. RSV is a major cause of infant hospitalization globally, and this new option aims to alleviate the burden on families and healthcare systems.
Clinical Trials
The CHMP's recommendation is supported by data from the Phase 2b/3 CLEVER trial and the Phase 3 SMART trial. These trials evaluated the safety and efficacy of ENFLONSIA™ in both preterm and full-term infants, as well as its performance against palivizumab in infants at increased risk for severe RSV disease. The results have been published in the New England Journal of Medicine.
Administration and Safety
ENFLONSIA™ is a long-acting monoclonal antibody designed to provide protection throughout a typical RSV season, which lasts about five months. It should not be administered to infants with a history of serious hypersensitivity reactions to any component of the drug.
