生物制药企业Axsome Therapeutics, Inc.（纳斯达克代码：AXSM）近日宣布，美国食品药品监督管理局（FDA）已正式受理其核心产品Axs-05针对阿尔茨海默病相关激越症状治疗的补充新药申请。此次申报同时获得FDA授予的优先审评资格，审评周期将缩短至6个月。
该突破性进展基于一项三期临床试验的积极结果。数据显示，Axs-05在改善阿尔茨海默病患者激越症状方面表现出显著疗效，且安全性特征良好。优先审评资格的授予意味着FDA认定该疗法有望为现有临床需求提供重要解决方案。
若最终获批，Axs-05将成为首个针对阿尔茨海默病激越症状的药物治疗方案。目前全球约有5000万阿尔茨海默病患者，其中约半数存在激越症状，该领域存在巨大未满足医疗需求。
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