Department of Radiology, Hospital of the University of Pennsylvania, Philadelphia, PA.
Clin Nucl Med. 2022 Jul 1;47(7):625-626. doi: 10.1097/RLU.0000000000004250. Epub 2022 Apr 22.
When the FDA granted accelerated approval of Biogen's Alzheimer disease drug, aducanumab (marketed as Aduhelm), it deviated from its mission of guaranteeing drug safety and efficacy because the approval was based exclusively on a perceived dose-dependent reduction in brain amyloid deposits and not upon a proven clinical effect. We believe that the amyloid-PET scans, perceived as showing decreasing amyloid deposits, are an expression of increased cerebral cell death due to aducanumab treatment, so that with time one should instead expect a worsening and not an improvement in the treated patients' condition.
当 FDA 批准百健公司的阿尔茨海默病药物 aducanumab（商品名为 Aduhelm）加速审批时，它偏离了保障药物安全性和有效性的使命，因为批准完全基于认为的剂量依赖性减少大脑淀粉样蛋白沉积，而不是基于已证明的临床效果。我们认为，淀粉样蛋白-PET 扫描被认为显示出淀粉样蛋白沉积减少，这是由于 aducanumab 治疗导致的大脑细胞死亡增加的表现，因此随着时间的推移，人们应该预期治疗患者的病情恶化而不是改善。
