Anavex Life Sciences has withdrawn its application for marketing authorization for Blarcamesine in the European Union and will gather additional information while continuing dialogue with the European Medicines Agency to resolve the issues raised by the Committee for Medicinal Products for Human Use.
The company has submitted additional information to the US Food and Drug Administration to discuss potential new drug applications for the treatment of early-onset Alzheimer’s disease.
Anavex is also leading regulatory collaborations with the European Union authorities for Blarkamesin for Parkinson’s disease and rare neurological conditions, including Rett syndrome. The publication reiterates that research use is not conclusive of efficacy or safety, and there is no guarantee that clinical development will lead to approval.
According to the company, Blarcamesine has completed Phase 2a and Phase 2b/3 trials in Alzheimer’s disease, Phase 2 proof-of-concept in Parkinson’s disease dementia, and Phase 2 and Phase 3 studies in adults, as well as Phase 2/3 studies in pediatric patients with Rett syndrome.
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