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NDA Submission for Major Depressive Disorder and Postpartum Depression Treatments
Sage Therapeutics and Biogen have announced their intention to formally submit a new drug application (NDA) to the United States Food and Drug Administration (FDA) for Zuranolone, a novel therapy for the treatment of both major depressive disorder (MDD) and postpartum depression (PPD).
Zuranolone is a once-daily, 2-week oral therapeutic currently being evaluated by the NEST and LANDSCAPE clinical trial programs. These programs are examining the effects of this therapeutic among several thousand participants with a variety of dosing, clinical endpoints, and treatment programs being studied.
The NEST program focuses on the treatment of PDD and includes 2 placebo-controlled studies, while the LANDSCAPE program analyzes the use of Zuranolone for MDD in 5 separate studies. Additional ongoing clinical trials are also being conducted to gather more data for the formal NDA submission. Zuranolone has already been granted Breakthrough Therapy Designation by the FDA, so the formal NDA package is the next step toward approval.
“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 4 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,” Barry Greene, Chief Executive Officer at Sage Therapeutics, stated in the Biogen news release. “We have identified what we believe is the most efficient path forward for an FDA filing and potential approval.”
The NDA package will be submitted for the use of Zuranolone to treat MDD in the second half 2022, and an additional, separate filing will be submitted for the treatment of PDD in first half of 2023, anticipates Sage Therapeutics and Biogen.
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