美国食品和药物管理局最初拒绝批准伊利利利的阿尔茨海默病药物Donanemab,因为安全性和有效性问题. FDA initially denied approval for Eli Lilly's Alzheimer's drug Donanemab due to safety and efficacy concerns.
BMJ 的一项调查引起了对礼来阿尔茨海默病药物 Donanemab 的严重担忧，尽管咨询小组成员在安全性、有效性和利益冲突方面存在问题，但该药物仍获得了 FDA 的批准。 An investigation by The BMJ raises significant concerns about Eli Lilly's Alzheimer's drug, Donanemab, which was approved by the FDA despite issues regarding safety, efficacy, and conflicts of interest among advisory panelists. 美国食品和药物管理局最初拒绝批准,理由是缺少数据的高率和因不良事件而停止治疗. The FDA initially denied approval, citing high rates of missing data and treatment discontinuation due to adverse events. 尽管缺乏临床上有意义的结果,但Lilly声称Donanemab减缓了疾病发展速度,引起专家的怀疑。 Despite lacking clinically meaningful results, Lilly claimed Donanemab slowed disease progression, raising skepticism among experts.