Biogen, Sage Pursue 2022 Filing for Depression Therapy, Zuranolone

On October 19th, Biogen and Sage Therapeutics announced plans for a New Drug Application (NDA) filing for their depression medication after a pre-NDA meeting held this fall. Both parties have decided to submit an NDA to the FDA in the second half of 2022 and seek approval of zuranolone for the treatment of major depressive disorder (MDD), as well as an additional filing for postpartum depression (PPD) in the first half of 2023.

Clinical studies, including LANDSCAPE and NEST programs, will be engaged as part of the approval process of the FDA. Additional CORAL study will be fully enrolled and closed to further screening with topline data anticipated in early 2022. To prevent any delay in the review timeline of MDD, Sage and Biogen have both agreed to submit a separate, distinct filing for PPD once the PPD 301-SKYLARK study is completed.

“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, CEO of Sage Therapeutics.

“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. We have identified what we believe is the most efficient path forward for an FDA filing and potential approval.”

Zuranolone for MDD and PPD

Zuranolone is an oral investigational two-week, once-daily therapeutic. It is a neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM), as the GABA system is a crucial inhibitory signaling pathway of the brain and central nervous system.

Major depressive disorder is a serious mood disorder that impacts patients’ social, occupational, educational or other significant functioning. Around 19 million people in the U.S. and over 250 million people worldwide suffer from MDD each year. A wider range of therapeutics is needed, though MDD has generally been treated with antidepressants.

Postpartum depression is one of the most common medical complications during and after pregnancy, in that it has affected more than 500,000 women annually. It causes severe functional impairment, depressed mood, and loss of interest in women’s newborns, as well as associated symptoms of depression, including loss of appetite, difficulty in sleeping, motor challenges, loss of energy, poor self-esteem, and lack of concentration.

“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., 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.”

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Judy Ya-Hsuan Lin

Success is the ability to go from one failure to another with no loss of enthusiasm.