Posted by Michael Wonder on 31 May 2018
Sage Therapeutics announces FDA acceptance of NDA filing and grant of priority review for brexanolone IV in the treatment of post-partum depression
30 May 2018 - If approved, brexanolone IV would be the first and only medication indicated for the treatment of post-partum depression.
Sage Therapeutics today announced that the U.S. FDA has accepted the filing of a new drug application for Sage’s lead product candidate, an intravenous formulation of brexanolone (SAGE-547) for the treatment of post-partum depression.
The submission was granted priority review status and the FDA assigned a Prescription Drug User Fee Act target date of 19 December 2018. As expected for a new molecular entity with a new mechanism of action, the FDA is currently planning to hold an advisory committee meeting to discuss the brexanolone IV application.
