Anavex Gets FDA Orphan Designation for Anavex2-73 in Fragile X Syndrome
November 07 2022 - 8:08AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
November 07, 2022 07:53 ET (12:53 GMT)
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