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Axsome Therapeutics: FDA Approves Auvelity to Treat Major Depressive Disorder in Adults

By Mary de Wet


Axsome Therapeutics Inc. said Friday that the U.S. Food and Drug Administration has approved Auvelity to treat major depressive disorder in adults.

Auvelity is the first oral treatment for the disorder, the biopharmaceutical company said. Axsome expects the drug will be commercially available in the U.S. in the fourth quarter.

The FDA had granted breakthrough therapy designation to the drug in March 2019 and evaluated the new drug application under priority review, the company said.

An estimated 21 million U.S. adults experienced major depressive disorder each year, Axsome said, citing the U.S. Department of Health and Human Services.


Write to Mary de Wet at


(END) Dow Jones Newswires

August 19, 2022 07:22 ET (11:22 GMT)

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