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DAYBU(trofinetide)RecommendedforApprovalintheEuropeanUnionbyCHMP
===2026/6/29 16:54:07===
发布时间:2026-06-29 13:10 -- European Commission decision expected in the coming months

-- If approved, DAYBU would become the first treatment for neurobehavioral symptoms of Rett syndrome in the European Union



SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion following a re-examination procedure, recommending the granting of a marketing authorization for DAYBU® (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. If granted marketing authorization by the European Commission, DAYBU® would be the first therapy approved for this indication in the European Union (EU).

“The CHMP’s positive opinion for DAYBU® is an important milestone in our mission to bring this innovative therapy to
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