Anavex OKd by CHMP to Submit Marketing Authorisation Application for Alzheimer’s

 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.

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.

https://www.globenewswire.com/news-release/2023/12/19/2798446/29248/en/Anavex-Received-Agreement-from-the-Committee-for-Medicinal-Products-for-Human-Use-CHMP-for-the-Submission-of-a-Marketing-Authorisation-Application-of-Oral-Blarcamesine-for-Alzheime.html