Sage Therapeutics and Biogen announced their plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone, an investigational two-week, once-daily therapeutic in the second half of 2022. The planned initial submission package will seek approval of zuranolone for the treatment of the major depressive disorder (MDD) and an additional filing for postpartum depression (PPD) is anticipated in the first half of 2023. The decision to apply follows recent discussions with the FDA, including a pre-NDA meeting held this fall. Data from completed studies in the Landscape and Nest programs, as well as data from the ongoing clinical and pharmacology studies, are planned to be included as part of the submission packages.

“In the pre-NDA meeting, the FDA’s response on the regulatory pathway for zuranolone continued to be consistent with previous discussions. In the clinical development programs, zuranolone has shown remarkably consistent, rapid, and sustained reductions in depressive symptoms, including anxiety and sleep loss, in addition to a well-tolerated safety profile. We believe we have a solid filing package with four adequate and well-controlled trials now in hand and, if approved, zuranolone will fill a real unmet need and be welcomed by people living with depression,” said Barry Greene, Chief Executive Officer at Sage Therapeutics. “We have identified what we believe is the most efficient path forward for an FDA filing and potential approval.”

Sage and Biogen also announced the Coral Study is fully enrolled and closed to further screening, with topline data expected in early 2022. The Coral Study is designed to demonstrate a rapid onset of depression relief when zuranolone is co-initiated with standard antidepressant therapy.

“We are pleased to share what we believe is an efficient filing pathway for zuranolone, to bring a new treatment option to the millions of people who suffer from depression worldwide,” said Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen. “The efficacy and safety data planned for FDA submission support our vision of zuranolone being an as-needed, two-week, once-daily treatment option for MDD and PPD that produces rapid relief from symptoms within days.”

Sage and Biogen plan to submit a separate and distinct filing for PPD once the ongoing PPD 301-SKYLARK Study completes so as not to affect the MDD review timeline. The companies plan to commence marketing for the approved indications as soon as possible pending the FDA’s approval. The review cycles may allow commercialization of both indications simultaneously if approved.