Biogen Inc., (NASDAQ: BIIB) and its partner Sage Therapeutics Inc., (NASDAQ: SAGE) have announced that the US Food and Drug Administration (FDA) has granted approval for Zurzuvae (zuranolone), marking it as the world’s first approved therapy for adults with postpartum depression (PPD). The approval is for Zurzuvae’s use as a 50mg once-daily oral treatment administered to patients over a two-week period.
FDA Declines Approval for Major Depressive Disorder (MDD) Indication
While the FDA approved Zurzuvae for PPD, it declined to approve the drug for a second indication of major depressive disorder (MDD), issuing a complete response letter (CRL) instead. The CRL highlighted insufficient evidence of effectiveness for the MDD indication and requested additional studies.
Zurzuvae: A First-In-Class Neuroactive Steroid
Discovered by Sage, Zurzuvae is a first-in-class neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). The GABA system, which Zurzuvae targets, is the major inhibitory signaling pathway in the brain and central nervous system, playing a crucial role in regulating brain function. Biogen acquired the rights to develop and commercialize Zurzuvae globally, excluding Japan, Taiwan, and South Korea, in a deal valued at USD 1.525 billion in November 2020. This included an upfront payment of USD 875 million and a USD 650 million equity investment in Sage.
Postpartum Depression: A Leading Cause of Maternal Mortality
US government data indicates that mental health conditions are the leading cause of maternal mortality, with postpartum depression being among the most common complications during and after pregnancy, affecting approximately one in eight women. The NEST trial, which supported Zurzuvae’s approval, demonstrated that the drug significantly reduced depressive symptoms by the third day of treatment, with effects sustained until day 45.-Fineline Info & Tech
