阿尔茨海默病治疗药物——aducanumab

A new drug for Alzheimer’s disease:aducanumab

aducanumab(商品名:Aduhelm)是一种高亲和力、靶向β淀粉样蛋白的单克隆抗体。2020年8月7日,美国食品药品管理局(FDA)宣布aducanumab生物制剂许可申请(BLA)获得优先审查。2021年6月7日,FDA通过加速审批途径批准aducanumab用于阿尔茨海默病(AD)患者治疗,并于2021年7月8日更新了aducanumab的说明书,将药物适用者限定为AD源性轻度认知功能障碍(MCI)以及轻度AD患者。本文对aducanumab的药理作用与机制、药物代谢动力学、临床疗效评价、安全性评价及用法用量等进行综述,旨在为临床合理使用提供参考。

Aducanumab(Aducanumab-avwa;AduhelmTM)is a high-affinity monoclonal antibody targeting amyloid-βprotein.On August 7,2020,the Food and Drug Administration(FDA)granted priority review to Aducanumab’s Biologics License application(BLA).On June 7,2021,the FDA granted accelerated approval to Aducanumab for patients with Alzheimer disease(AD),and on July 8,2021,the label was updated to restrict its use to patients with AD-induced mild cognitive impairment(MCI)and mild AD.This article reviews the pharmacological action and mechanism,pharmacokinetics,clinical efficacy evaluation,safety evaluation,usage and dosage of Aducanumab,aiming to provide a reference for clinical rational use.