Anavex Life Sciences withdrew its marketing authorization application in the EU for blarcamesine as an add-on therapy for early Alzheimer’s disease after the European Medicines Agency’s Committee for Medicinal Products for Human Use indicated it would not be in a position to issue a positive opinion.
On 25 March, Anavex said it will consider the CHMP feedback and focus on gathering additional data and conducting further analyses to address the points raised. The application was submitted in October 2023, following encouragement from the EMA SME Office to prepare and apply for marketing authorization.
According to the company, blarcamesine (ANAVEX®2-73) has completed Phase 2a and Phase 2b/3 trials in Alzheimer’s disease and has been studied in Parkinson’s disease dementia and Rett syndrome; the company claims preclinical data show potential disease-modifying effects.
