Sage, Biogen To File New Drug Application To FDA For Zuranolone

Sage Therapeutics, Inc. (SAGE), a biopharmaceutical company , and Biogen Inc. (BIIB), a biotechnology firm, on Tuesday said they plan to submit a New Drug Application or NDA to the U.S. Food and Drug Administration for Zuranolone, an investigational two-week, once-daily therapeutic in the second half of 2022.

The planned initial submission package is expected to seek approval of zuranolone for the treatment of major depressive disorder (MDD) and an additional filing for postpartum depression (PPD) is anticipated in the first half of 2023.

The decision to submit the application follows recent discussions with the FDA, including a pre-NDA meeting held this fall, the companies said in a statement.

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," said Barry Greene, Chief Executive Officer at Sage Therapeutics.

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

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