Sage Therapeutics, Biogen to Seek FDA Approval of Zuranolone in 2nd Half of 2022

By Colin Kellaher

Sage Therapeutics Inc. and Biogen Inc. on Tuesday said they plan to seek U.S. Food and Drug Administration approval for their antidepressant drug candidate zuranolone in the second half of 2022.

The companies said they plan to start a rolling submission early next year, and the initial package will seek approval of zuranolone for the treatment of major depressive disorder.

Sage and Biogen said the decision follows recent discussions with the FDA, noting that they expect the current efficacy and safety databases to be adequate for filing.

Sage and Biogen said they plan an additional filing for postpartum depression in the first half of 2023.

Sage and Biogen, both based in Cambridge, Mass., late last year signed a global collaboration and license agreement to jointly develop and commercialize zuranolone for major depressive disorder, postpartum depression and other psychiatric disorders.

The companies in June said a Phase 3 study of the drug in major depressive disorder met its primary endpoint, showing statistically significant improvement in symptoms compared with placebo.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

October 19, 2021 07:25 ET (11:25 GMT)

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