Biogen, Sage Get FDA Priority Review of Zuranolone
February 06 2023 - 7:18AM
Dow Jones News
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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