Axsome Therapeutics旗下抑郁症疗法扩大适应症获FDA优先审评

智通财经2025-12-31

专注于开发和商业化中枢神经系统(CNS)疾病新型疗法的生物制药公司 Axsome Therapeutics, Inc. 周三宣布，美国食品药品监督管理局(FDA)已对其提交的、旨在扩大其抑郁症疗法AXS-05(商品名：Auvelity)适应症至阿尔茨海默病激越症状的上市申请授予优先审评资格。该公司在一份声明中表示，针对AXS-05的补充新药申请，FDA已将2026年4月30日设定为目标审评完成日期...

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