Anavex (AVXL) Life Sciences announced the submission of the blarcamesine Marketing Authorization Application, MAA, to the European Medicines Agency, EMA. The MAA submission is for the treatment of Alzheimer’s Disease. Overall, blarcamesine, a small molecule administered orally once daily, demonstrated clinically meaningful improvement over 48 weeks with primary endpoint ADAS-Cog13 score being larger than 2 points. This suggests superior numerical clinical efficacy compared to approved therapies while also slowing neurodegeneration in early AD patients. Blarcamesine’s safety profile indicates not requiring routine MRI monitoring, and the advantage of blarcamesine is that it is a small oral molecule that exerts clinical benefits on cognition and neurodegeneration and could be appealing because of its easy and convenient route of administration and good comparative safety profile.
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