Eli Lilly and Company (LLY) Tuesday announced that the U.S. Food and Drug Administration's Advisory Committee will convene a meeting on Donanemab for early symptomatic Alzheimer's disease.The Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) will convene a meeting on Monday, June 10, 2024, to discuss Donanemab, which Eli Lilly has submitted for the treatment of early symptomatic Alzheimer's disease.

礼来公司周二宣布，美国食品和药物管理局咨询委员会将召开一次关于多纳单抗治疗早期症状性阿尔茨海默病的会议。外周和中枢神经系统药物咨询委员会（PCNS）将于2024年6月10日（星期一）召开会议，讨论多纳单抗，礼来公司已将其用于治疗早期症状性阿尔茨海默病。

The open public hearing portion of the meeting will be conducted virtually.The Phase 3 study submitted as part of this application, TRAILBLAZER-ALZ 2, is a double-blind, placebo-controlled study to evaluate the safety and efficacy of Donanemab in participants ages 60-85 years with early symptomatic Alzheimer's disease with the presence of confirmed Alzheimer's disease neuropathology..

会议的公开听证会部分将以虚拟方式进行。作为本申请的一部分提交的3期研究TRAILBLAZER-ALZ 2是一项双盲，安慰剂对照研究，旨在评估多纳单抗在60-85岁患有早期症状性阿尔茨海默病且存在确诊阿尔茨海默病神经病理学的参与者中的安全性和有效性。。

Alzheimer's disease is a progressive and fatal disease that in its early symptomatic stages affects 6-7.5 million Americans. The trial enrolled 1,736 participants, across eight countries, selected based on cognitive assessments in conjunction with amyloid plaque imaging and tau staging by positron emission tomography (PET) imaging.

阿尔茨海默氏病是一种进行性致命疾病，在其早期症状阶段影响600-750万美国人。该试验招募了来自八个国家的1736名参与者，这些参与者是根据认知评估结合淀粉样斑块成像和正电子发射断层扫描（PET）成像的tau分期选择的。