Anavex Life Sciences withdrew its application for marketing authorization of Blarcamesine in the European Union and will gather additional data while continuing dialogue with the European Medicines Agency to address points raised by the Committee for Medicinal Products for Human Use.
The company has submitted additional data to the U.S. Food and Drug Administration with the objective of discussing potential pathways toward a New Drug Application for the treatment of early Alzheimer’s disease.
Anavex is also advancing regulatory engagement with EU authorities on Blarcamesine for Parkinson’s disease and rare neurological conditions, including Rett syndrome. The release reiterates that investigational uses are not conclusions about efficacy or safety and that there is no guarantee clinical development will result in approval.
According to the company, Blarcamesine has completed Phase 2a and Phase 2b/3 trials in Alzheimer’s disease, a Phase 2 proof of concept in Parkinson’s disease dementia, and Phase 2 and Phase 3 studies in adults, plus a Phase 2/3 study in pediatric patients with Rett syndrome.
