On March 25, 2026, Anavex Life Sciences Corp. announced the withdrawal of its application for marketing authorization of blarcamesine as an add-on therapy for early Alzheimer's disease in adults. This decision follows feedback from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), which indicated that it would not be in a position to issue a positive opinion for the application at this time. The company remains committed to the ongoing clinical development of blarcamesine and is focused on addressing the concerns raised by the CHMP. Anavex had initially submitted the application in October 2023 after encouragement from the EMA's SME Office, which had advised the company to prepare for the application. The withdrawal of the application is a setback for Anavex, which has been working to develop innovative treatments for Alzheimer's disease and other CNS disorders. The company plans to gather additional data and conduct further analyses to address the points raised by the CHMP, demonstrating its commitment to advancing potential therapeutic options for patients with significant unmet medical needs.

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