In early June 2021, the U.S. Food and Drug Administration (“FDA”) granted Accelerated Approval to Aducanumab (“Aduhelm”) for treating Alzheimer’s disease. The decision was immediately engulfed in controversy because the agency ignored the Scientific Drugs Advisory Committee’s unanimous recommendation not to approve the drug. The FDA granted the approval based on Aduhelm’s ability to lower beta-amyloid levels. However, the agency had not previously indicated this as a surrogate clinical end for the trial, and its own scientific analysis failed to show that amyloid changes correlate with cognitive or functional changes for Alzheimer’s patients. This decision sets dangerous precedent and has the potential to transform the approval process for new drugs including, but not limited to, those meant to treat Alzheimer’s.

2021 年 6 月上旬，美国食品药品监督管理局 (“FDA”) 加速批准 Aducanumab (“Aduhelm”) 用于治疗阿尔茨海默病。该决定立即引起争议，因为该机构无视科学药物咨询委员会不批准该药物的一致建议。FDA 基于 Aduhelm 降低 β-淀粉样蛋白水平的能力授予了批准。然而，该机构此前并未将此作为试验的替代临床终点，其自身的科学分析未能表明淀粉样蛋白的变化与阿尔茨海默病患者的认知或功能变化相关。这一决定开创了危险的先例，并有可能改变新药的批准程序，包括但不限于那些旨在治疗阿尔茨海默氏症的药物。