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Sage Readies Zurzuvae For December Launch With Slow Ramp As Payer Talks Progress

No Update On Plans For MDD Resubmission

 
• By Mandy Jackson

Sage and Biogen set a $15,900 list price for Zurzuvae, the 14-day postpartum depression drug approved in the US in August, and expect broad access but formulary discussions will continue into 2024.

Wooden blocks with launching rocket graphic arranged in pyramid shape and a man is holding the top one.
Sage has finished building its commercial team for the December launch • Source: Shutterstock

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

  • Sage said Zurzuvae will launch for PPD in December now that the DEA has scheduled the drug.

  • The company and partner Biogen set a $15,900 list price for a 14-day course of treatment, which analysts viewed as higher than expected

Sage said as part of its third quarter financial update on 7 November that Zurzuvae will officially reach the market in December now that the DEA has given the oral drug – a positive allosteric modulator of the GABA-A receptor – a Schedule IV classification, meaning the product has low potential for abuse and a low risk of dependence

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