The U.S. Food and Drug Administration (FDA) recently informed Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) that it does not intend to convene an advisory committee meeting to discuss the New Drug Application (NDA) for zuranolone, which is being developed for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). This news comes as exciting developments for the two companies, as they endeavor to bring relief to those suffering from these difficult conditions.
Zuranolone, an investigational therapy for Major Depressive Disorder and Postpartum Depression, has been granted priority review by the FDA. With a PDUFA action date of August 5, 2023, this 14-day, rapid-acting, once-daily, oral treatment has the potential to revolutionize the treatment of mood disorders in adults.
About ZURANOLONE
Zuranolone, an investigational drug in development, could offer a once-daily, 14-day relief to those suffering from major depressive disorder (MDD) and postpartum depression (PPD). This neuroactive steroid (NAS) works by activating the GABA-A receptor, a key part of the inhibitory signaling system of the central nervous system that plays a critical role in regulating brain function. If approved, Zuranolone could be a potential breakthrough for those affected by depressive disorders.
Shionogi’s two clinical development programs, LANDSCAPE and NEST, are currently exploring the potential benefits of zuranolone as a treatment. Across five studies in the LANDSCAPE program, thousands of people with MDD are being given different doses, endpoints, and treatments. The NEST program takes a closer look at two studies of zuranolone in women with PPD, the ROBIN and SKYLARK studies. To top it off, a Phase 2 study of zuranolone in Japan has recently been completed. As we eagerly await the results of these studies, we anticipate the potential therapeutic effects of zuranolone.
About Sage Therapeutics
At Sage Therapeutics, we are on a mission to revolutionize brain health and promote a world where everyone can thrive. We are fearlessly leading the charge to develop life-changing medicines that can improve the lives of people living with brain-related conditions. Our team is passionate about creating solutions that can bring hope and make a positive difference in the lives of those we serve.
About Biogen
For more than four decades, Biogen has been a global leader in biotechnology, pushing the boundaries of scientific discovery and revolutionizing patient care. Through breakthrough innovations such as the first approved treatment for spinal muscular atrophy, a portfolio of medicines to treat multiple sclerosis, and two co-developed treatments to address Alzheimer’s disease, Biogen is dedicated to advancing humanity through science and creating a healthier, more sustainable, and equitable world. Today, Biogen is committed to discovering and developing novel therapies across neurology, neuropsychiatry, specialized immunology, and rare diseases to improve the lives of people everywhere.