Record mula sa primary source
Decision-gradeOpinyon ng EMA
Acadia: Inaprubahan ng EC ang DAYBU (trofinetide) para sa Rett syndrome sa EU
Nagbigay ang European Commission ng marketing authorization para sa DAYBU (trofinetide) para sa neurobehavioral symptoms ng Rett syndrome sa mga adult at pediatric patients na may edad na limang taon pataas, na ginagawa itong unang at tanging aprubadong gamot para sa Rett syndrome sa EU. Ang pag-apruba ay batay sa mga resulta ng Phase 3 LAVENDER study na nagpapakita ng statistically significant improvements sa core Rett syndrome features. Sisimulan na ngayon ng Acadia ang pricing at reimbursement negotiations sa mga national authorities sa 27 EU member states kasama ang Iceland, Liechtenstein, at Norway.
Mahahalagang fact
- Na-file
- Ago 24, 2026, 07:01 AM
- Kaganapan
- Opinyon ng EMA
- Direksyon
- Positibo
- Kumpanya
ACADAcadia- Asset
- trofinetide
- Pinagmulan
- Press release ng kumpanya
- Kumpiyansa
- May source
Sipi mula sa source
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
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Materyal
Hun 26, 2026
10:49 AM
ACADAcadia