卫材(ESALY.US)向FDA提交仑卡奈单抗皮下注射剂型的滚动补充生物制品许可申请

Core Viewpoint - Eisai and Biogen have initiated a rolling supplemental Biologics License Application (sBLA) to the FDA for the subcutaneous auto-injector formulation of Lecanemab (IQLIK) for early Alzheimer's disease patients, having received Fast Track designation from the FDA [1] Group 1: Product Development - The sBLA submission is based on an 18-month core study and a sub-study from the Phase 3 Clarity AD open-label extension study, evaluating the subcutaneous administration method across multiple dosage ranges [1] - If approved, the IQLIK 500mg subcutaneous dosing regimen (two 250mg injections) will provide an alternative to the current intravenous (IV) administration, allowing patients to receive treatment at home from initiation to maintenance [1] Group 2: Treatment Benefits - The subcutaneous formulation is expected to reduce the complexities associated with IV maintenance therapy, such as infusion preparation and nursing supervision, thereby simplifying the overall treatment process for Alzheimer's disease [1] - The injection time for the IQLIK auto-injector is approximately 15 seconds, enhancing convenience for patients and caregivers [1]