金吾财讯 | 美国FDA正式批准Biogen(BIIB)与卫材(ESALF、ESAIY)联合研发的阿尔茨海默病治疗药物Leqembi皮下注射剂型，全新剂型可同时满足患者初始治疗与长期维持治疗需求，且支持居家自主注射使用，大幅优化患者治疗便捷度，完善病症全程治疗体系。
新版皮下注射剂型设置标准化给药方案，初始治疗阶段给药频率为每周一次，单次总剂量500毫克，分两次注射完成，单针注射时长约15秒；患者完成18个月初始疗程后，转入维持治疗阶段，调整为每周一次360毫克固定剂量。临床使用规则明确，患者可根据自身治疗需求，在皮下注射与传统静脉注射两种剂型之间灵活切换，适配不同治疗场景。
本次剂型获批基于严谨的临床对比数据，临床试验证实，Leqembi皮下注射剂型的治疗效果、药效稳定性与原有静脉注射剂型高度一致，疗效水平无显著差异。居家可注射剂型的落地，有效解决了传统静脉注射需医疗机构操作、就医频次高的痛点，降低患者治疗门槛，扩大该款创新药物的临床普及范围，为阿尔茨海默病长期慢病管理提供全新解决方案。
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