ARTICLE | Clinical News
Sage postpartum depression candidate gets Priority Review
June 1, 2018 7:31 PM UTC
Sage Therapeutics Inc. (NASDAQ:SAGE) said FDA accepted and granted Priority Review to an NDA for brexanolone (SAGE-547) to treat postpartum depression (PPD). Its PDUFA date is Dec. 19.
In November, the therapy met the primary endpoints in two Phase III trials to treat PPD. Brexanolone is a positive allosteric modulator (PAM) of GABA A receptor (see BioCentury, Nov. 10, 2017)...
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