European Medicines Agency recommends Dupixent for young children with atopic dermatitis
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The European Medicines Agency has recommended extending Dupixent approval to treat severe atopic dermatitis in children aged 6 months to 5 years in the European Union, Regeneron Pharmaceuticals and Sanofi announced in a press release.
The recommendation from the agency’s Committee for Medicinal Products for Human Use is specifically for candidates of systemic therapy in this indication.
The recommendation was supported by data from a phase 3 trial that evaluated Dupixent (dupilumab) in children aged 6 months to 5 years. The study, which was published in The Lancet, met all primary and secondary endpoints, improving skin clearance and disease severity at 16 weeks. Compared with placebo, children taking Dupixent also reported a reduction in itch and skin pain and improved sleep quality and health-related quality of life. Long-term data showed sustained improvement up to 1 year.
Dupixent, a fully human monoclonal antibody, was approved by the FDA for children aged 6 months to 5 years in June 2022, and the drug has been approved in both the United States and European Union to treat other indications.
Regeneron Pharmaceuticals and Sanofi anticipate a final decision from the European Commission concerning the drug’s application in the coming months, according to the press release.
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