SAGE

By Colin Kellaher

Biogen Inc. and Sage Therapeutics Inc. on Monday said the U.S. Food and Drug Administration granted priority review to the application seeking approval of zuranolone for the treatment of major depressive disorder and postpartum depression.

The Cambridge, Mass., companies said the agency set a target action date of Aug. 5 for the application.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.

Sage and Biogen said zuranolone, a 14-day, fast-acting oral treatment, has the potential to provide a meaningful new option to help address the significant unmet medical need in depression.

The companies in 2020 inked a global collaboration and license agreement to jointly develop and commercialize zuranolone for major depressive disorder, postpartum depression and other psychiatric disorders.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

February 06, 2023 07:03 ET (12:03 GMT)

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