The US Food and Drug Administration approval of Zurzuvae (zuranolone) in August did not go according to plan for Sage Therapeutics, Inc. and partner Biogen, Inc. While it was cleared to treat postpartum depression (PPD), the companies received a complete response letter (CRL) indicating an additional clinical trial would be needed to support approval in major depressive disorder (MDD), but the drug’s launch for new mothers with PPD is now progressing as expected following Drug Enforcement Administration scheduling.
Key Takeaways
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Sage said Zurzuvae will launch for PPD in December now that the DEA has scheduled the drug.
Sage said as part of its third quarter financial update on 7 November that Zurzuvae will officially reach the market...
