1차 출처 기록
결정급FDA 승인
Axsome Therapeutics: FDA, AUVELITY의 알츠하이머병 관련 초조증 적응증 승인
FDA가 알츠하이머병으로 인한 치매 관련 초조증 치료제로 AUVELITY(dextromethorphan HBr/bupropion HCl)를 승인했습니다. 이 승인은 위약 대비 초조증 증상 개선과 재발까지의 시간 연장에서 통계적으로 유의한 결과를 보인 3상 ADVANCE-1 및 ACCORD-2 시험에 기반합니다. AUVELITY는 해당 적응증에 대해 Breakthrough Therapy 지정과 Priority Review를 받았습니다.
핵심 사실
출처 발췌
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