A committee at the European Medicines Agency (EMA) recommended extending Enflonsia’s EU eligibility to children still at risk of severe respiratory syncytial virus (RSV) in a second season, with final authorization pending.
EMA’s Committee for Medicinal Products for Human Use made the recommendation on Nov. 12. EMA lists clesrovimab as Enflonsia’s active substance.
Under the existing EU label, neonates and infants are eligible during season one. The CHMP recommended adding children no older than 24 months who continue to face a risk of severe RSV disease in a second RSV season.
The European Commission must decide whether to amend the EU marketing authorization. After the Commission decides, EMA plans to post revised use guidance in an updated summary of product characteristics.
