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Reprioritization On Cards After Sage/Biogen’s Zurzuvae Receives CRL For MDD

Despite PPD Approval

 
• By Ayisha Sharma

The firms’ Zurzuvae has become the first oral drug to win US approval for postpartum depression but a thumbs down in the larger major depressive disorder indication has raised concerns that Biogen could pull out of the partnership as Sage turns its efforts to cutting costs.  

woman sitting on floor with head down next to baby in crib
PPD Affects Around 500,000 Women In The US • Source: Shutterstock
Key Takeaways:

  • Zurzuvae was approved in PPD but with the caveat of black box warnings that could limit uptake.

Sage Therapeutics, Inc./Biogen, Inc.’s GABA-a receptor positive allosteric modulator, zuranolone, has won US Food and Drug Administration approval for postpartum depression (PPD) under the brand name Zurzuvae, but a rejection in major depressive disorder (MDD) has surprised analysts and significantly dampened sales potential.

The FDA approved 50mg Zurzuvae as the first oral, once-daily, 14-day treatment for PPD based on data from the pivotal...

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