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Sage/Biogen Delay Zuranolone Filing, Commercial Path Remains Unclear

 
• By Alaric DeArment

The companies will seek approval for zuranolone in MDD second-half 2022 and in PPD in first-half 2023, but that also means launch will probably happen second-half 2023.

DEPRESSION miserable depressed , Depression and its consequences, Depressed emotions concept , alone in depression - Image
Sage/Biogen provided a clear path to approval for zuranolone, though it pushed out their NDA filing to 2H22 • Source: Shutterstock

Sage Therapeutics, Inc. and Biogen, Inc. have again pushed out their filing plans for the antidepressant zuranolone, but their plan provides a clearer – albeit slightly riskier – path to market than before.

The companies said 19 October that they would file with the US Food and Drug Administration for zuranolone in major depressive disorder (MDD) in the second half of 2022, subsequently...

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