原始来源记录
决策级FDA 批准
Axsome Therapeutics：FDA批准AUVELITY用于阿尔茨海默病激越
FDA批准AUVELITY（氢溴酸右美沙芬/盐酸安非他酮）用于阿尔茨海默病所致痴呆相关的激越。该批准基于3期ADVANCE-1和ACCORD-2试验，显示与安慰剂相比，激越症状有统计学显著改善且复发时间更长。AUVELITY获得突破性疗法认定和优先审评用于此适应症。
关键事实
- 申报时间
- 2026年4月30日 21:19
- 事件
- FDA 批准
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
来源摘录
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