Therapy Areas: Central Nervous System
Sage Therapeutics, Biogen Initiate Rolling Submission of New Drug Application to US Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder
3 May 2022 - - US-based biopharmaceutical company Sage Therapeutics, Inc. (NASDAQ: SAGE) and US-based neuroscience specialist Biogen Inc. (NASDAQ: BIIB) have initiated a rolling submission of a New Drug Application to the US Food and Drug Administration for zuranolone in the treatment of major depressive disorder, the companies said.

Zuranolone is an investigational two-week, once-daily oral drug being developed for MDD and postpartum depression.

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.

Data from the completed studies of zuranolone 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, will comprise the full submission package.

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

Zuranolone was granted Fast Track Designation by the FDA in 2017 in MDD and Breakthrough Therapy Designation in 2018. Sage and Biogen plan to submit an associated NDA filing for PPD in the first half of 2023.

Zuranolone (SAGE-217/BIIB125) is a once-daily, two-week, investigational drug in development for the treatment of major depressive disorder and postpartum depression.

Zuranolone is an investigational 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.

Zuranolone has been granted Fast Track and Breakthrough Therapy Designation for MDD and Fast Track Designation for PPD by the US Food and Drug Administration.

Zuranolone is being evaluated in the LANDSCAPE and NEST clinical development programs. The two development programs include multiple studies examining use of zuranolone in several thousand people with a variety of dosing, clinical endpoints, and treatment paradigms.

The LANDSCAPE program includes five studies of zuranolone in people with MDD (MDD-201B, MOUNTAIN, SHORELINE, WATERFALL, and CORAL Studies).

The NEST program includes two placebo-controlled studies of zuranolone in people with PPD (ROBIN and SKYLARK Studies).

Additionally, Shionogi completed a Phase 2 study of zuranolone in Japan in people with MDD.

One of the world's first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp.

Today, Biogen has a portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and is providing the first and only approved treatment to address a defining pathology of Alzheimer's disease.
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