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New Drug Application to be submitted for MDD in late 2022, with separate filing for PPD planned for early 2023.
More good news regarding treatment choices in major depressive disorder (MDD) and postpartum depression (PPD), as the 2 companies working on zuranolone announced that they will submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA).
Following discussions with the FDA, including a pre-NDA meeting this fall, Biogen Inc. and Sage Therapeutics Inc. decided to initially seek FDA approval of zuranolone in the treatment of MDD in late 2022, with plans to file for PPD in the first half of 2023. The initial submission package for MDD will include data from ongoing pharmacology and clinical studies, plus data from the LANDSCAPE and NEST clinical trial program studies, both of which include several studies examining the effectiveness of zuranolone in several thousand patients in various dosing, treatment paradigms, and clinical endpoints. Data from PPD 301-SKYLARK, a NEST program ongoing placebo-controlled study of zuranolone in patients with PPD, will be added to the separate filing for PPD. 1
“We are pleased to share what we believe is an efficient filing pathway for zuranolone, with the goal of bringing a new treatment option to the millions of people who suffer from depression worldwide,” said Alfred Sandrock Jr, MD, PhD, Head of Research and Development at Biogen, in a press release.
Zuranolone is a once-daily, 2-week, investigational oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM) in development for the treatment of MDD and PPD that is designed to potentially serve as a rapid-acting sustainable treatment option. The drug received the Breakthrough Therapy Designation from the FDA in February 2018.2
Recently, Sage shared results from their SHORELINE study, which found the agent to be safe and effective in the sample of patients with MDD.3 In that trial, investigators found that almost half of all participants who positively responded to the initial 14-day course of zuranolone 30 mg did not require additional treatment to maintain wellness through a year of follow-up.
“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, in a press release. “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.”
1. Sage Therapeutics and Biogen announce plans to submit a New Drug Application (NDA) for zuranolone to the U.S. Food and Drug Administration in the second half of 2022 with rolling submission expected to start in early 2022. News Release. Sage Therapeutics. October 19, 2021. Accessed October 19, 2021. https://investor.sagerx.com/news-releases/news-release-details/sage-therapeutics-and-biogen-announce-plans-submit-new-drug
2. Sage Therapeutics receives FDA Breakthrough Therapy Designation for SAGE-217 for the treatment of major depressive disorder. News Release. Sage Therapeutics. February 7, 2018. Accessed October 19, 2021. https://investor.sagerx.com/news-releases/news-release-details/sage-therapeutics-receives-fda-breakthrough-therapy-designation
3. Kuntz L. Anticipated phase 3 interim results for Sage’s depression treatment, zuranolone. Psychiatric Times. October 14, 2021. Accessed October 19, 2021. https://www.psychiatrictimes.com/view/anticipated-phase-3-interim-results-for-sage-s-depression-treatment-zuranalone