Anavex Life Sciences Corp. (NASDAQ:AVXL) has withdrawn its application seeking marketing authorization in the European Union for blarcamesine as a treatment for early-stage Alzheimer’s disease, the company said.
The biopharmaceutical group noted that discussions with the European Medicines Agency are ongoing as it works to address issues raised by the Committee for Medicinal Products for Human Use. Anavex said it intends to collect additional data and perform further analyses to support the continued development of the drug.
The company also reported that it has submitted additional information to the U.S. Food and Drug Administration in an effort to align on the future development pathway for blarcamesine in Alzheimer’s disease within the United States. The aim is to explore potential regulatory routes toward filing a New Drug Application for the treatment of early Alzheimer’s disease.
In parallel, Anavex said it has been engaging with European regulators about the potential use of blarcamesine in Parkinson’s disease as well as in rare conditions such as Rett syndrome.
“We remain committed about advancing the development of innovative oral therapies for patients living with both neurodegenerative diseases, including early Alzheimer’s and Parkinson’s disease and neurodevelopmental disorders as we continue our engagement with regulatory authorities,” said Christopher U. Missling, the company’s president and chief executive officer.
Blarcamesine has previously completed Phase 2a and Phase 2b/3 trials in Alzheimer’s disease, a Phase 2 study in Parkinson’s disease dementia, and both Phase 2 and Phase 3 trials in adults with Rett syndrome, along with a Phase 2/3 trial in pediatric patients with Rett syndrome.
The oral drug candidate works by targeting SIGMAR1 and muscarinic receptors, with the goal of restoring cellular balance. Anavex is focused on developing therapies for neurodegenerative, neurodevelopmental and neuropsychiatric conditions.