Catatan sumber primer
PenentuPersetujuan FDA
Axsome Therapeutics: FDA menyetujui AUVELITY untuk agitasi Alzheimer
FDA menyetujui AUVELITY (dextromethorphan HBr/bupropion HCl) untuk agitasi terkait demensia akibat penyakit Alzheimer. Persetujuan didukung oleh uji coba Phase 3 ADVANCE-1 dan ACCORD-2 yang menunjukkan perbaikan gejala agitasi secara signifikan secara statistik dan waktu lebih lama hingga relaps dibandingkan plasebo. AUVELITY menerima penetapan Breakthrough Therapy dan Priority Review untuk indikasi ini.
Fakta utama
- Diajukan
- 30 Apr 2026, 21.19
- Peristiwa
- Persetujuan FDA
- Arah
- Positif
- Perusahaan
AXSMAxsome- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
Kutipan sumber
EX-99.1 2 axsm-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Axsome Therapeutics Announces FDA Approval of AUVELITY ® (dextromethorphan HBr and bupropion HCl) for the Treatment of Agitation Associated with Dementia due to Alzheimer’s Disease AUVELITY is a first-in-class treatment, which targets the NMDA and sigma-1 receptors, approved for agitation associated with dementia due to Alzheimer’s disease The safety and tolerability profile of AUVELITY in agitation associated with dementia due to Alzheimer’s disease has been established across short-term and long-term trials AUVELITY was developed with FDA Breakthrough Therapy designation and evaluated by the FDA under Priority Review Company to host webcast Friday, May 1, at 8:00 AM Eastern Time NEW YORK, April 30, 2026, (Globe Newswire) – Axsome