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

Despite PPD Approval

07 Aug 2023

• 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.
The CRL in MDD surprised most analysts as the pivotal WATERFALL trial had met its primary endpoint.
Sage is planning a reprioritization that could include pipeline and job cuts with further details to come.

Sage Therapeutics, Inc./Biogen, Inc

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

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