Sage Therapeutics and Biogen initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Zuranolone in the treatment of major depressive disorder (MDD). Zuranolone is an investigational two-week, once-daily oral drug being developed for MDD and postpartum depression (PPD). The companies have submitted the nonclinical module of the NDA to the FDA and plan to submit the remaining components for the MDD filing in the second half of 2022.

Data from the completed studies of Zuranolone in the LANDSCAPE and NEST clinical development programs, including data from the ongoing open-label SHORELINE Study in MDD, as well as data from the completed clinical pharmacology studies, will comprise the full submission package. The rolling submission process allows completed sections of an NDA to be submitted to the FDA for review on an ongoing basis.

“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.”

“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, M.D., M.P.H., 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.”

Zuranolone was granted Fast Track Designation by the FDA in 2017 in MDD and Breakthrough Therapy Designation in 2018. Sage and Biogen plan to submit an associated NDA filing for PPD in the first half of 2023.