Rolling NDA Submission of Zuranolone for Treatment of Major Depressive Disorder

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Sage Therapeutics and Biogen initiated a rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD). Zuranolone is a 2-week, once-daily oral drug for the treatment of MDD and postpartum depression (PPD). The companies submitted the nonclinical module to the FDA and plan to submit all remaining components for MDD in the latter half of 2022.

“Zuranolone has the potential to help address a significant unmet medical need in depression as an innovative option in a therapeutic area where little has changed in the past 30 years,” said Priya Singhal, MD, MPH, Head of Global Safety and Regulatory Sciences and Interim Head of R&D at Biogen. “We are committed to advancing the science and developing new approaches to treating mental health, a major public health challenge that was exacerbated by the COVID-19 pandemic.”

The submission package will include: data from the completed studies of zuranolone in the LANDSCAPE and NEST clinical development programs, data from the ongoing open-label SHORELINE Study in MDD, and data from completed clinical pharmacology studies.

“There are millions of people living with depression and the initiation of the rolling NDA submission brings us one step closer to our goal of offering zuranolone as a potential new treatment option,” said Barry Greene, Chief Executive Officer at Sage. “We believe the results from the LANDSCAPE and NEST programs, in which zuranolone demonstrated rapid and sustained effects and a well-tolerated safety profile in clinical trials, support zuranolone as a potential novel treatment option for MDD, if approved. We look forward to providing an update when the rolling submission for zuranolone in MDD is complete, which we expect to occur in the second half of this year.”

In 2017, zuranolone was granted fast track designation by the FDA in MDD, and breakthrough therapy designation in 2018. Sage and Biogen intend to submit an associated NDA filing for PPD in the first half of 2023.

Reference

1. Sage Therapeutics and Biogen initiate rolling submission of new drug application (NDA) to U.S. Food and Drug Administration for zuranolone for the potential treatment of major depressive disorder (MDD). Sage Therapeutics. May 2, 2022. https://investor.sagerx.com/news-releases/news-release-details/sage-therapeutics-and-biogen-initiate-rolling-submission-new