First marketing authorization submission for blarcamesineNEW YORK – November 26, 2024   Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) diseases, today announced the submission of the blarcamesine (ANAVEX®2-73) MAA (Marketing Authorization Application) to the European Medicines Agency (EMA).

blarcamesineNEW YORK的首次上市授权提交–2024年11月26日Anavex Life Sciences Corp.（“Anavex”或“公司”）（纳斯达克：AVXL），一家临床阶段的生物制药公司，开发用于治疗阿尔茨海默病，帕金森病，精神分裂症，神经发育，神经退行性疾病和罕见疾病（包括Rett综合征）以及其他中枢神经系统（CNS）疾病的差异化疗法，今天宣布向欧洲药品管理局（EMA）提交blarcamesine（Anavex®2-73）MAA（上市授权申请）。

The MAA submission is for the treatment of Alzheimer’s Disease.Overall, blarcamesine, a small molecule administered orally once daily, demonstrated clinically meaningful improvement over 48 weeks with primary endpoint ADAS-Cog13 score being larger than 2 points. [1] This suggests superior numerical clinical efficacy compared to approved therapies while also slowing neurodegeneration in early AD patients.

MAA提交用于治疗阿尔茨海默病。总体而言，blarcamesine是一种每天口服一次的小分子，在48周内表现出临床上有意义的改善，主要终点ADAS-Cog13评分大于2分。[1] 这表明与批准的疗法相比，具有优越的数值临床疗效，同时也减缓了早期AD患者的神经退行性变。

Blarcamesine’s safety profile indicates not requiring routine MRI monitoring, and the advantage of blarcamesine is that it is a small oral molecule that exerts clinical benefits on cognition and neurodegeneration and could be appealing because of its easy and convenient route of administration and good comparative safety profile.There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 2030, according to the European Brain Council.[2] The World Health Organization (WHO) estimated the cost in Europe of caring for people with dementia, including Alzheimer's disease, at $439 billion, or $31,144 per person in 2019.

Blarcamesine的安全性表明不需要常规MRI监测，Blarcamesine的优点是它是一种小的口服分子，对认知和神经退行性疾病具有临床益处，并且由于其简单方便的给药途径和良好的比较安全性，可能具有吸引力。据欧洲大脑理事会（European Brain Council）统计，欧洲估计有700万人患有阿尔茨海默氏病，预计到2030年这一数字将翻一番。[2] 世界卫生组织（WHO）估计，2019年，欧洲照顾痴呆症（包括阿尔茨海默病）患者的费用为4390亿美元，即每人31144美元。

That includes hospital care, medicines, diagnostics, informal caregiver time, community services and long-term care facility .

这包括医院护理、药品、诊断、非正式护理时间、社区服务和长期护理设施。