Anavex Gets FDA Approval For Orphan Drug Designation for Frontotemporal Dementia Treatment


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Anavex Life Sciences Corp (OTC: AVXL) said the FDA has granted orphan drug status to its ANAVEX 3-71 for frontotemporal dementia or FTD treatment. The company said in a statement that FTD described a clinical syndrome connected with the progressive shrinking of the frontal, as well as temporal anterior lobes of the brain. As a result, it causes a drop in language and behavioral changes, according to the company.


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Anavex Life Sciences CEO Christopher Missling commented, "This regulatory milestone allows us to continue to advance in the rare disease space while expanding our portfolio within neurodegenerative diseases."

The company's VP of Regulatory Affairs Kristina Capiak said, "We believe that Orphan Drug Designation for ANAVEX 3-71 for the treatment of Frontotemporal dementia is a significant achievement." In the United States alone, about 50,000–60,000 patients were estimated to have been affected by FTD.

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