CHMP Recommends DAYBU for EU Approval

The European Union — Committee for Medicinal Products for Human Use (CHMP) of the European Union — European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for DAYBU (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. This recommendation, based on results from the Phase 3 LAVENDER study, is a crucial step towards making DAYBU the first approved therapy for this indication in the European Union (EU). Acadia Pharmaceuticals Inc., the developer of DAYBU, anticipates a final decision from the International — European Commission in the coming months. If approved, the marketing authorization would extend to all 27 EU member states, as well as Iceland, Liechtenstein, and Norway, addressing a significant unmet medical need for patients and caregivers affected by Rett syndrome.