Rolling submission of NDA begins for FDA on daily oral drug for depression

Sage Therapeutics and Biogen Inc. announced they have initiated a rolling submission for a New Drug Application to the FDA for zuranolone, a once-daily oral drug being developed to treat major depressive disorder.

The companies stated they have submitted the nonclinical module of the NDA and plan to submit the remaining portions in the second half of the year. Remaining information will include completed studies of zuranolone from the LANDSCAPE and NEST clinical development programs, which include data from the ongoing open-label SHORELINE study, as well as 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,” Sage Therapeutics CEO Barry Greene, said in a released statement.

“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.”

Zuranolone was granted fast track designation by the FDA in 2017 for MDD, and then breakthrough therapy designation in 2018. The companies plan to submit an associated NDA filing for postpartum depression in the first half of 2023.

“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,” Priya Singhal, MD, MPH, Biogen’s head of global safety and regulatory sciences, said in the released statement. “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.”