Coerver Katherine, Yu Melissa M, D'Abreu Anelyssa, Wasserman Marc, Nair Kavita V
Rocky Mountain Neurology (KC), Lone Tree, CO; Baylor College of Medicine (MMY), Houston, TX; University of Virginia (AD), Charlottesville; Blue Sky Neurology (MW), Englewood, CO; Department of Neurology (KVN), School of Medicine, and Department of Clinical Pharmacy (KN), Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora.
Neurol Clin Pract. 2022 Apr;12(2):169-175. doi: 10.1212/CPJ.0000000000001144.
Aducanumab (Aduhelm), developed by the biotechnology firm Biogen in Cambridge, MA, was approved using the less common accelerated approval pathway by the Federal Drug Administration (FDA) reserved for treatments that fill a significant unmet need. Its approval on June 7, 2021, has been met with an outpouring of opinions from prescribers, insurers, advocacy groups, and hospital systems regarding its risk-benefit profile. Originally approved for all forms of Alzheimer disease (AD), the FDA updated aducanumab's labeling on July 8, 2021, for "treatment in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials." With 6 million people nationally in the United States who suffer from AD and an anticipated one-third of those who may now fulfill the criteria under the revised labeling, the implications of aducanumab's approval continue to generate national interest..
由马萨诸塞州剑桥市的生物技术公司百健（Biogen）研发的阿杜卡单抗（Aduhelm），通过联邦药物管理局（FDA）不太常见的加速批准途径获得批准，该途径专为满足重大未满足需求的治疗方法保留。2021年6月7日其获批后，开处方者、保险公司、倡导团体和医院系统就其风险效益情况发表了大量意见。阿杜卡单抗最初获批用于所有形式的阿尔茨海默病（AD），2021年7月8日，FDA更新了阿杜卡单抗的标签，用于“治疗轻度认知障碍（MCI）或疾病轻度痴呆阶段的患者，即临床试验中开始治疗的人群”。美国全国有600万人患有AD，预计其中三分之一的人现在可能符合修订后标签的标准，阿杜卡单抗获批的影响继续引起全国关注。
