NEW YORK, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, announced today that the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) agreed that oral blarcamesine for Alzheimer’s disease is eligible for submission of an application for a Union Marketing Authorisation in the EU under the European Medicines Agency’s centralised procedure.

2023年12月19日，纽约（环球通讯社）--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，开发用于治疗神经退行性疾病和神经发育障碍的差异化疗法，今天宣布，欧洲药品管理局（EMA）内的人类使用药品委员会（CHMP）同意，根据欧洲药品管理局的集中程序，治疗阿尔茨海默病的口服blarcamesine有资格在欧盟提交欧盟上市许可申请。

The granting of the eligibility from the CHMP under the centralised procedure allows for submission of a single Marketing Application to the European Medicines Agency that, if approved, would allow blarcamesine to be marketed in all EU member states. Anavex is aiming to submit the Marketing Authorisation Application as early as possible in 2024.

根据集中程序从CHMP获得资格允许向欧洲药品管理局提交单一的营销申请，如果获得批准，将允许在所有欧盟成员国销售blarcamesine。Anavex的目标是在2024年尽早提交上市许可申请。

“We appreciate the CHMP/EMA’s decision to deem blarcamesine eligible for a centralised regulatory review,” said Anavex’s Christopher U Missling, PhD, President and Chief Executive Officer. “We understand that there is a need for scalable and accessible treatments options which can be pragmatically administered like oral blarcamesine not requiring any complex additional procedures for the treatment of people with Alzheimer’s disease.” There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 20301, which could be addressed by blarcamesine.

Anavex的总裁兼首席执行官Christopher U Missling博士表示：“我们感谢CHMP/EMA决定将blarcamesine视为有资格进行集中监管审查。”。“我们了解到，需要可扩展且可获得的治疗方案，这些方案可以像口服blarcamesine一样实用，不需要任何复杂的额外程序来治疗阿尔茨海默氏病。”据估计，欧洲有700万阿尔茨海默氏病患者，预计到20301年人数将翻一番，blarcamesine可以解决这个问题。

Since blarcamesine requires only a physician assessed diagnosis of Alzheimer’s disease and not any invasive amyloid positron emission tomography (PET) scans or lumbar punctures (spinal tap), the potential addressable market for blarcamesine consist of a broa.

由于blarcamesine只需要医生评估的阿尔茨海默氏病诊断，而不需要任何侵入性淀粉样正电子发射断层扫描（PET）扫描或腰椎穿刺（脊柱穿刺），因此blarcamesine的潜在目标市场由broa组成。