Anavex Gets FDA Orphan Designation for Anavex2-73 in Fragile X Syndrome

By Colin Kellaher

Anavex Life Sciences Corp. on Monday said the U.S. Food and Drug Administration granted orphan-drug designation to its lead drug candidate, Anavex2-73, for the treatment of Fragile X syndrome, a leading genetic cause of autism.

The New York clinical-stage biopharmaceutical company said it plans to rapidly advance Anavex2-73 as a potential treatment for Fragile X syndrome while expanding late-stage studies of the drug candidate in Alzheimer's disease, Parkinson's disease and Rett syndrome.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S., and provides for an extended marketing exclusivity period against competition.

Anavex said there are currently no FDA-approved treatments for Fragile X syndrome, with an estimated U.S. population of about 62,500.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

November 07, 2022 07:53 ET (12:53 GMT)

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