原始出處紀錄
決策級FDA 核准
Axsome Therapeutics：FDA 核准 AUVELITY 用於阿茲海默症激動症狀
FDA 核准 AUVELITY（dextromethorphan HBr/bupropion HCl）用於治療阿茲海默症所致失智症的激動症狀。此核准依據 Phase 3 ADVANCE-1 與 ACCORD-2 試驗，顯示在激動症狀改善及相較安慰劑延長復發時間方面具統計學顯著意義。AUVELITY 獲得突破性療法認定及優先審查資格，用於此適應症。
關鍵事實
- 申報時間
- 2026年4月30日 下午09:19
- 事件
- FDA 核准
- 方向
- 正面
- 來源
- SEC 8-K
- 可信度
- 有出處
來源摘錄
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