卫材启动针对早期阿尔茨海默病的 Leqembi® 皮下自动注射器的滚动 BLA 审批；获得 FDA 快速通道认定。 Eisai initiates rolling BLA for Leqembi® subcutaneous autoinjector for early Alzheimer's disease; FDA Fast Track designated.

卫材已向美国 FDA 提交了一份滚动生物制品许可申请 (BLA)，用于治疗早期阿尔茨海默病的 Leqembi® (lecanemab-irmb) 皮下自动注射器的每周维持剂量。 Eisai has initiated a rolling Biologics License Application (BLA) to the US FDA for Leqembi® (lecanemab-irmb) subcutaneous autoinjector for weekly maintenance dosing in early Alzheimer's disease. 此前，该药物获得了 FDA 快速通道认证。 This follows the drug receiving Fast Track designation by the FDA. 如果获得批准，皮下注射 Leqembi 将可以在家中或医疗机构中使用，比目前的静脉注射剂型更为方便。 If approved, the subcutaneous Leqembi would be administered at home or in medical facilities, providing a more convenient option than the current intravenous formulation.

May 15, 2024

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