Acadia: यूरोपीय आयोग ने रेट सिंड्रोम के लिए DAYBU (trofinetide) को EU में मंजूरी दी

The European Commission granted marketing authorization for DAYBU (trofinetide) for neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older, making it the first and only approved treatment for Rett syndrome in the EU. The approval is based on the Phase 3 LAVENDER study results showing statistically significant improvements in core Rett syndrome features. Acadia will now begin pricing and reimbursement negotiations with national authorities in the 27 EU member states plus Iceland, Liechtenstein, and Norway.

मुख्य तथ्य

फाइल किया गया: 24 अग॰ 2026, 07:01 am
घटना: EMA की राय
दिशा: सकारात्मक
कंपनी: ACADAcadia
संपत्ति: trofinetide
स्रोत: कंपनी की प्रेस विज्ञप्ति
विश्वसनीयता: स्रोत सहित

स्रोत का अंश

European Commission Approves DAYBU® (trofinetide) as the First and Only Treatment for Neurobehavioral Symptoms of Rett Syndrome in the European Union European Commission Approves DAYBU® (trofinetide) as the First and Only Treatment for Neurobehavioral Symptoms of Rett Syndrome in the European Union European Commission Approves DAYBU® (trofinetide) as the First and Only Treatment for Neurobehavioral Symptoms of Rett Syndrome in the European Union Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the European Commission (EC) has granted marketing authorization for DAYBU (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older, making it the first and only treatment approved for Rett syndrome in th

कंपनी की प्रेस विज्ञप्ति