Sage and Biogen File NDA for Fast-Acting Postpartum Depression Drug

Collaboration partners Sage Therapeutics and Biogen have announced that the FDA has accepted the filing of a New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an investigational drug being evaluated as a 14-day, rapid-acting, once-daily, oral treatment in adults with MDD and PPD.

The NDA has been granted priority review by the FDA with an action date of August 5, 2023. Priority Review is granted by the FDA to applications for medicines that, if approved, would provide significant improvements in the effectiveness or safety of the treatment, diagnosis, or prevention of serious conditions.

“We feel a tremendous responsibility to patients with MDD and PPD to deliver a potential new treatment option, which is so desperately needed. Most current approved therapies may take weeks or months to work. We are committed to advancing treatments that could help physicians and patients by addressing depression symptoms quickly,” said Laura Gault, M.D., Ph.D., Chief Medical Officer at Sage.

Depression is one of the leading contributors to disability worldwide. It is estimated that more than 21 million adults in the U.S. experienced at least one major depressive episode in 2020, with nearly 14 million people diagnosed with major depressive disorder, and an estimated 500,000 cases of PPD annually. Symptoms of MDD and PPD have been shown to have an impact on a person’s overall quality of life, functioning and well-being. In 2018, the incremental economic burden of MDD was an estimated $326 billion in the U.S. alone.

Zuranolone, a neuroactive steroid, has a novel mechanism of action as a positive allosteric modulator of GABA-A receptors. The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes to regulating brain function. In people with depression, zuranolone is thought to work by rapidly rebalancing dysregulated neuronal networks to help reset brain function, targeting brain networks responsible for functions such as mood, arousal, behavior, and cognition. (Source: Sage Therapeutics Website, 06 February, 2023)