Departments of Neurology, Psychiatry, Neuroscience, Cognitive Science, Organizational Behavior, and Design and Innovation, Case Western Reserve University, Cleveland, OH, USA.
Professor of Medicine (Neurology), University of Toronto, Toronto, Ontario, Canada.
J Alzheimers Dis. 2022;87(3):1003-1007. doi: 10.3233/JAD-220262.
The controversial approval in June 2021 by the Food and Drug Administration (FDA) of aducanumab (marketed as Aduhelm), Biogen's monoclonal antibody for patients with Alzheimer's disease, raises significant concerns for the dementia field and drug approval process, considering its lack of adequate evidence for clinical efficacy, safety issues, and cost. On 15 December 2021, an international group of clinicians, basic science experts, psychological and social science researchers, lay people with lived experience of dementia, and advocates for public health met to discuss making a recommendation for whether aducanumab's approval should be withdrawn. Attendees considered arguments both in favor of and in opposition to withdrawal and voted unanimously to recommend that the FDA withdraw its approval for aducanumab and to support the Right Care Alliance's filing of a formal Citizen Petition to this effect.
2021 年 6 月，食品和药物管理局 (FDA) 批准了 Biogen 用于治疗阿尔茨海默病的单克隆抗体 aducanumab（商品名为 Aduhelm），这引发了痴呆症领域和药物审批流程的重大担忧，因为该药物缺乏足够的临床疗效证据、存在安全问题和高昂的成本。2021 年 12 月 15 日，一个由临床医生、基础科学专家、心理和社会科学研究人员、有痴呆症生活经历的普通人和公众健康倡导者组成的国际团体开会讨论是否应该撤回 aducanumab 的批准。与会者考虑了赞成和反对撤回的论点，并一致投票建议 FDA 撤回对 aducanumab 的批准，并支持“正确护理联盟”就此提出正式的公民请愿。
