This latest submission completes the FDA filing that was initiated in May.
The rolling submission of a new drug application (NDA) for zuranolone to the US Food and Drug Administration (FDA) has been completed.
Zuranolone is an investigational drug by Sage Therapeutics and Biogen that is being evaluated as a potential rapid-acting, once-daily, 14-day, oral short course treatment for major depressive disorder (MDD) and postpartum depression (PPD) in adults. According to data from its LANDSCAPE and NEST development programs, zuranolone has demonstrated rapid and sustained improvement of depressive symptoms, a consistent safety profile, and generally good tolerability.1
This week’s submission completes the NDA that was initiated by Sage Therapeutics and Biogen in May 2022.2 Zuranolone has already received FDA Fast Track and Breakthrough Therapy Designations for MDD in 2017 and 2018, respectively, as well as Fast Track Designation for PPD in 2022.1
“Based on the data in the LANDSCAPE and NEST programs, we believe that zuranolone has the potential to be a meaningful new therapy for depression,” said Priya Singhal, MD, MPH, head of global safety and regulatory sciences and interim head of R&D at Biogen, in a press release. “We look forward to working with the FDA as this filing progresses.”
1. Sage Therapeutics and Biogen complete rolling submission of new drug application for zuranolone in the treatment of major depressive disorder and postpartum depression. Press release. Business Wire. December 6, 2022. Accessed December 7, 2022. https://www.businesswire.com/news/home/20221205005815/en/Sage-Therapeutics-and-Biogen-Complete-Rolling-Submission-of-New-Drug-Application-for-Zuranolone-in-the-Treatment-of-Major-Depressive-Disorder-and-Postpartum-Depression
2. Kuntz L. Rolling NDA submission of zuranolone for treatment of major depressive disorder. Psychiatric Times. May 2, 2022. Accessed December 7, 2022. https://www.psychiatrictimes.com/view/rolling-nda-submission-of-zuranolone-for-treatment-of-major-depressive-disorder