智通财经APP获悉，9月4日，卫材(Eisai)和渤健(Biogen)宣布，卫材(ESALY.US)已启动向美国FDA提交仑卡奈单抗皮下自动注射剂型(SC-AI)IQLIK作为每周起始剂量的滚动补充生物制品许可申请(sBLA)，此前FDA已授予快速通道资格。仑卡奈单抗用于治疗患有轻度认知障碍及轻度痴呆的早期阿尔茨海默病(AD)患者。
此次补充生物制品许可申请(sBLA)的提交基于，针对早期阿尔茨海默病患者群体开展的18个月核心研究后、在3期Clarity AD开放标签扩展研究(OLE)的子研究中对皮下(SC)给药方式在多剂量范围内的评估。
若美国FDA批准仑卡奈单抗IQLIK 500mg皮下给药方案(两次250mg注射)，该自动注射剂型可用于每周一次的起始剂量给药，作为每两周一次静脉注射(IV)的替代方案。这将使患者及照料者能够从治疗初始到维持阶段在家接受仑卡奈单抗治疗，提供静脉注射与皮下注射两种给药方式的选择。目前每支仑卡奈单抗IQLIK自动注射剂型的注射时间约为15秒。皮下制剂有望减少与静脉维持给药相关的输液准备和护士监护等环节，同时简化阿尔茨海默病的整体治疗流程。
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