智通财经APP获悉，1月26日，卫材(ESALY.US)和渤健(BIIB.US)共同宣布仑卡奈单抗(Lecanemab，商品名：Leqembi)静脉注射(IV)制剂的补充生物制品许可申请(sBLA)获得FDA批准，用于每4周1次维持治疗早期阿尔茨海默病(AD)患者，即存在轻度认知障碍或处于轻度痴呆阶段的AD患者。
早期AD患者需在起始阶段先接受每两周1次(Q2W)的仑卡奈单抗治疗，然后再接受每月1次的仑卡奈单抗治疗，以此维持有效的药物浓度从而清除有毒的原纤维(即使在淀粉样蛋白β(Aβ)斑块从大脑中清除后，这些原纤维仍会继续存在导致神经元损伤)。
AD是一种持续的神经毒性过程，在Aβ斑块沉积之前开始并在Aβ斑块沉积之后持续进展。治疗早期AD是当务之急，因为在早期进行持续治疗可以减缓AD的进展。AD引起的轻度认知障碍和轻度痴呆越早得到诊断和治疗，患者获益的机会就越大。
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