Anavex Life Sciences withdraws EU marketing authorization application for blarcamesine; EMA CHMP feedback drops chances of a positive opinion

Reuters03-25
Anavex Life Sciences withdraws EU marketing authorization application for blarcamesine; EMA CHMP feedback drops chances of a positive opinion
  • Anavex Life Sciences withdrew its application for the marketing authorization of blarcamesine in the EU as an add-on therapy for the treatment of early Alzheimer’s disease in adults, narrowing its near-term regulatory pathway in the region.
  • Feedback from the EMA’s Committee for Medicinal Products for Human Use indicated it would not be in a position to issue a positive opinion at this time, shifting the company’s focus toward additional data generation and further analyses.
  • Chief Executive Officer Christopher U. Missling said the company plans to continue engagement with regulatory authorities, aiming to preserve longer-term commercial potential in early Alzheimer’s disease.


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