Biogen, Sage Therapeutics File NDA for Zuranolone to Treat Major Depressive Disorder

The companies expect to complete the submission to the FDA for MDD in the first half of 2022 and an associated filing for postpartum depression in 2023.

Biogen and Sage Therapeutics have submitted a new drug application (NDA) to the FDA for zuranolone for the treatment of major depressive disorder (MDD).

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.

“There are millions of people living with depression, and the initiation of the rolling NDA submission brings us 1 step closer to our goal of offering zuranolone as a potential new treatment option,” Barry Greene, CEO at Sage Therapeutics said in the 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.”

The data from the completed studies of the drug 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, were submitted as part of the application.

The development programs include multiple studies that examine the use of zuranolone in several thousands of individuals with a variety of clinical endpoints, dosing, and treatment paradigms. The LANDSCAPE program includes 5 studies for individuals with MDD, and the NEST program includes 2 placebo-controlled studies for individuals with postpartum depression (PPD).

The rolling submission process allows completed sections of an NDA to be submitted to the FDA for review on an ongoing basis.

“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, head of Global Safety and Regulatory Sciences and interim head of research and development at Biogen, said in the 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.”

Zuranolone is an investigational once-daily, oral, 2-week drug being developed for the treatment of MDD and PPD. It is an oral neuroactive steroid GABA-A receptor positive allosteric modulator.

The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes to regulating brain function.

It was granted fast-track designation by the FDA in 2017 for MDD and breakthrough therapy designation in 2018. The companies plan to submit an associated NDA filing for PPD in the first half of 2023.

“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,” Green said.

Reference

Sage Therapeutics and Biogen initiate rolling submission of new drug application (NDA) to US Food and Drug Administration for zuranolone for the potential treatment of major depressive disorder (MDD). Biogen. News release. May 2, 2022. Accessed May 3, 2022. http://media.biogen.com/news-releases/news-release-details/sage-therapeutics-and-biogen-initiate-rolling-submission-new