FDA accepts NDA for zuranolone against depression

FDA accepts NDA for zuranolone against depression | Image Credit: © JHVEPhoto - © JHVEPhoto - stock.adobe.com.

The FDA has accepted a New Drug Application (NDA) for zuranolone (SAGE-217; SAGE Therapeutics) as a method of treatment for major depressive disorder (MDD) and postpartum depression (PPD), according to Biogen Inc and Sage Therapeutics.

“We see potential for zuranolone, if approved, to be a meaningful new option that can help address the serious unmet need faced by the diverse populations struggling with MDD and PPD,” said Priya Singhal, MD, MPH, executive vice president, head of development and interim head of research and global safety and regulatory sciences at Biogen.

Zuranolone is being evaluated for a once daily, 14-day oral regimen in adult patients with MDD or PDD. Over 21 million individuals in the United States experienced 1 or more major depressive episode in 2020, and almost 14 million were diagnosed with MDD and 500,000 with PPD. 

Quality of life, functioning, and well-being are impacted by depression, making it one of the leading contributors to disability worldwide. MDD had an estimated burden of $326 billion in the United States in 2018.

The NDA for zuranolone includes data from the NEST and LANDSCAPE clinical development programs and a phase 2 study from Japan evaluating the drug in adult patients with MDD. Two studies of zuranolone in adult women with PDD comprise the NEST program, while 5 studies in adults with MDD comprise the LANDSCAPE program.

According to Laura Gault, MD, PhD, chief medical officer at Sage, most therapies currently approved for depressive symptoms might take weeks or months before taking effect. Zuranolone may be a method which addresses symptoms sooner.

Zuranolone is, “a neuroactive steroid, has a novel mechanism of action as a positive allosteric modulator of GABA-A receptors.” It restarts brain function by rebalancing dysregulated neuronal networks, targeting networks responsible for behavior, cognition, arousal, and mood.

The FDA had granted zuranolone priority review. This status is given to medications which significantly improve safety or efficacy of treatment. It has been given a Prescription Drug User Fee Act date of August 5, 2023.

Reference

Biogen and Sage Therapeutics announce FDA accepts filing of new drug application and grants priority review of zuranolone in the treatment of major depressive disorder and postpartum depression. Biogen. February 6, 2023. Accessed July 27, 2023. https://investors.biogen.com/news-releases/news-release-details/biogen-and-sage-therapeutics-announce-fda-accepts-filing-new