The antibody aducanumab this week became the first new Alzheimer's disease drug approved in the United States since 2003, and the first ever that aims to interfere with the underlying disease process. In a controversial decision, the U.S. Food and Drug Administration overruled its advisers to approve aducanumab, an intravenously delivered antibody developed by Biogen and marketed as Aduhelm, based on evidence that it clears a toxic form of the protein beta amyloid, which accumulates in the brains of people with Alzheimer's and is widely thought to drive neuronal damage. The decision came despite thin and conflicting evidence from two large clinical trials about the drug's ability to slow patients' cognitive decline.

本周抗体 aducanumab 成为自 2003 年以来在美国批准的第一个新的阿尔茨海默病药物，也是有史以来第一个旨在干扰潜在疾病过程的药物。在一项有争议的决定中，美国食品和药物管理局否决了其顾问批准 aducanumab，这是一种由 Biogen 开发并以 Aduhelm 销售的静脉注射抗体，基于证据表明它可以清除积聚在大脑中的有毒形式的蛋白质 β 淀粉样蛋白患有阿尔茨海默氏症的人，被广泛认为会导致神经元损伤。尽管来自两项大型临床试验关于该药物减缓患者认知能力下降的能力的证据薄弱且相互矛盾，但还是做出了这一决定。