A European Medicines Agency committee has recommended expanding use of Merck’s Enflonsia to help prevent respiratory syncytial virus in certain children up to 24 months old who remain at increased risk of severe disease during their second RSV season.
The Committee for Medicinal Products for Human Use adopted a positive opinion on the expanded indication, Merck said Friday. The treatment is intended to prevent RSV, a lower respiratory tract disease, in eligible children who continue to face elevated risk after their first season of infection.
The European Commission will review the recommendation before deciding whether to authorize marketing in the European Union, Iceland, Liechtenstein and Norway. Merck expects a final decision within the next two months.
“For some children, the risk of severe RSV does not end after their first RSV season and they remain at increased risk for serious cases of RSV-related bronchiolitis or pneumonia that can require hospitalization,” said Macaya Douoguih, therapeutic area head of global clinical development at Merck Research Laboratories. Douoguih said the committee’s opinion is an important step toward making Enflonsia available to at-risk children in the region.
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