Anavex Life Sciences Corp. ("Anavex" or the "Company") (NASDAQ:AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today provides a comprehensive regulatory update.
Following the withdrawal of the application for the marketing authorization of blarcamesine in the EU, Anavex will continue to gather additional data and conduct further analyses to advance the development program in early Alzheimer's disease. The dialogue continues with the EMA to address the points raised by the Committee for Medicinal Products for Human Use (CHMP).
As part of our ongoing interactions with the FDA, Anavex has submitted additional data to the regulatory agency with the objective of reaching alignment on the Alzheimer's disease development program for blarcamesine in the U.S.
Anavex is also advancing regulatory engagement with EU authorities for blarcamesine in Parkinson's disease and rare neurological conditions, including Rett syndrome, underscoring the breadth of the Company's clinical development portfolio.