NDA for Biogen-Sage’s Zuranolone Accepted by FDA, Marking Another Step Forward in Depression Drug Development

On February 6, Sage Therapeutics and Biogen announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for Zuranolone, an investigational drug for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). 

The FDA has assigned the drug a Priority Review designation and a Prescription Drug User Fee Act (PDUFA) action date of August 5, 2023, indicating that a final decision regarding drug approval will be reached within the coming 6 months. 

Related article: Biogen, Sage Pursue 2022 Filing for Depression Therapy, Zuranolone

Significant Unmet Need Raised by MDD and PPD

MDD is a common but serious mood disorder that can have severe consequences for patients in terms of their social, occupational, and educational functioning. It was estimated that there were 190 million cases of MDD worldwide in 2020. In the U.S. alone, approximately 21.0 million adults and 4.1 million adolescents (aged 12 to 17) had at least one major depressive episode in 2020, representing 8.4% of all adults and 17.0% of all adolescents in the country. Besides, from 2010 to 2018, the estimated incremental economic burden of MDD in the U.S. increased from $236.6 billion to $326.2 billion.

PPD is considered to be a major medical complication during and after pregnancy. It can negatively impact a woman in a number of ways, including significant functional impairment, low mood, loss of interest in her newborn, as well as associated depressive symptoms such as loss of appetite, difficulty sleeping and lack of concentration. Each year, PPD is estimated to affect approximately 1 in 8 women who have given birth in the U.S. or approximately 500,000 women.

Potential Rapid-acting Treatment for MDD and PPD

Zuranolone is an oral neuroactive steroid (NAS) being evaluated as a 14-day, rapid-acting, once-daily, oral treatment in adults with MDD and PPD. The drug acts as a positive allosteric modulator of GABA-A receptors and targets brain networks responsible for functions such as mood, arousal, behavior, and cognition. It is thought to work by rapidly rebalancing patients’ dysregulated neuronal networks to help reset their brain functions.

In November 2020, Biogen and Sage entered into a partnership agreement to jointly develop and commercialize Zuranolone in the U.S. The two companies began submitting Zuranolone’s NDA to the FDA in the second half of 2022 with rolling submissions, and the process was completed in December 2022.

Zuranolone’s NDA contains data from the NEST and LANDSCAPE clinical development programs. The former includes 5 clinical studies in adults with MDD while the latter comprises 2 studies in adult women with PPD. In addition, data from a Phase 2 study of Zuranolone completed by Shionogi in Japan in people with MDD are also included in the NDA. 

The Team Anticipates Launch of Zuranolone in Late 2023

Apart from the acceptance of the NDA, the FDA also granted Zuranolone the status of priority review. With the FDA decision date for the approval scheduled on August 5, Sage and Biogen remain hopeful that Zuranolone can be launched in the second half of 2023.

According to Laura Gault, M.D., Ph.D., Chief Medical Officer at Sage, most currently approved therapies may take weeks or months to work. This poses an urgent need for new treatments that can address depression symptoms quickly. “We believe Zuranolone, if approved, could offer a new way for physicians to support patients,” said Gault.

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Richard Chau