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New depression drug zuranolone one step closer to FDA ruling

Nature Medicine explores the latest translational and clinical research news, with a New Drug Application from Sage Therapeutics and Biogen for their GABA receptor agonist.
  1. Thiago Carvalho

    1. Lisbon, Portugal.

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Image credit: Denis Pobytov / DigitalVision Vectors / Getty

The US Food and Drug Administration (FDA) recently accepted Sage Therapeutics and Biogen’s filing for a New Drug Application for its orally available GABAA receptor agonist, zuranolone (SAGE-217), for the treatment of major depressive disorder and postpartum depression. The February announcement was followed by the FDA’s notification in March that it was unlikely to convene an advisory committee to review the application. The agency is scheduled to issue its ruling by 5 August 2023.

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Nature Medicine 29, 1032-1033 (2023)

doi: https://doi.org/10.1038/d41591-023-00032-8

The Clinical Pipeline is a column on translational and clinical research, from bench to bedside

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