根据礼来公开新闻稿介绍，名为TRAILBLAZER-ALZ 2的3期研究显示，疾病进展最早期的患者使用donanemab的效果最好。在18个月的试验期内，参与者被分到两组人群中进行分析：疾病进展较早期的一组(具有低至中等水平的tau蛋白)和整体人群，包括低、中和高tau水平受试者。研究表明，donanemab可显著减缓具有阿尔茨海默病早期症状患者的认知与功能下降、延缓疾病进展。On December 18, Eli Lilly and Company (LLY.US) just announced that the company's marketing application for the Class 1 new drug donanemab injection has been approved by the China National Drug Administration (NMPA).
The Zhitong Finance App learned that on December 18, Eli Lilly and Company (LLY.US) just announced that the company's marketing application for the Class 1 new drug, donanemab injection, has been approved by the China National Drug Administration (NMPA). According to the NMPA Drug Evaluation Center (CDE) priority review announcement, the drug has now been approved to treat early-stage Alzheimer's disease, that is, treatment should begin when the patient is in the mild stage of cognitive impairment or mild dementia.
Donanemab is a medicine used for intravenous infusion, which is injected every four weeks. This product was first approved by the US FDA in July 2024 to treat adults with Alzheimer's disease with early symptoms (trade name: Kisunla). The drug was previously selected for the “Top Ten Potentially Major R&D Pipelines 2024” list selected by industry media Evaluate. Furthermore, Eli Lilly's previous press release stated that donanemab is the first amyloid plaque-targeted therapy with evidence that treatment can be stopped after amyloid plaques have been removed, so it is expected that this treatment can reduce treatment costs and reduce the number of infusions.
According to Eli Lilly's public press release, a phase 3 study called TRAILBLAZER-ALZ 2 showed that patients with the earliest progression of the disease had the best effect of using donanemab. Over an 18-month trial period, participants were divided into two groups of people for analysis: a group with early disease progression (with low to moderate levels of tau protein) and the overall population, including subjects with low, medium and high levels of tau. Research shows that donanemab can significantly slow cognitive and functional decline and delay disease progression in patients with early symptoms of Alzheimer's disease.
