Anavex Life Sciences Corp. (NASDAQ:AVXL) has withdrawn its application for European Union marketing authorization for blarcamesine as an add-on treatment for early Alzheimer’s disease. The decision follows feedback from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) indicating that the application was unlikely to receive a favorable opinion.
The biotechnology company had submitted the filing after earlier encouragement from the EMA’s SME Office in October 2023. At that time, agency representatives had advised Anavex to “immediately begin preparing” its submission and suggested that applying for marketing authorization should be the company’s next step.
Anavex said it will review the feedback from the committee and concentrate on collecting additional data and conducting further analyses to address the issues raised by regulators. The company added that it remains committed to continuing the clinical development of blarcamesine for individuals with early-stage Alzheimer’s disease.
“We remain dedicated to advancing the development of innovative oral therapies for patients living with early Alzheimer’s disease and to continuing our engagement with regulatory authorities,” said Christopher U. Missling, the company’s president and chief executive officer.
Blarcamesine is an oral drug candidate designed to act on SIGMAR1 and muscarinic receptors. The therapy has completed Phase 2a and Phase 2b/3 trials for Alzheimer’s disease, along with clinical studies targeting Parkinson’s disease dementia and Rett syndrome. Anavex focuses on developing treatments for neurodegenerative, neurodevelopmental, and neuropsychiatric conditions.