FDA接受Axsome提出的AXS-05治疗老年痴呆症的申请,预计于2026年4月30日作出决定。 FDA accepts Axsome’s application for AXS-05 to treat Alzheimer’s agitation, with a decision expected by April 30, 2026.

林业发展局接受了AXS-05用于治疗阿尔茨海默氏病激动症的Axosome治疗疗法SNDA,并给予优先审查,以便在2026年4月30日之前作出决定。 The FDA has accepted Axsome Therapeutics’ sNDA for AXS-05 to treat agitation in Alzheimer’s disease and granted Priority Review, aiming for a decision by April 30, 2026. 该申请以第三阶段试验数据为基础,寻求核准已经核准用于抑郁症的口服药物。 The application, based on Phase 3 trial data, seeks approval for an oral drug already approved for depression. 阿尔茨海默氏症患者中,76%的阿尔茨海默氏病患者受到影响,与更快下降和照顾者负担增加有关。 Agitation affects up to 76% of Alzheimer’s patients and is linked to faster decline and greater caregiver burden. 由于该药物有可能解决未得到满足的医疗需要,因此加快了审查速度。 The review is expedited due to the drug’s potential to address an unmet medical need.