FDA to not hold panel meeting for Biogen, Sage's depression therapy zuranolone
Iryna Drozd


Biogen (NASDAQ:BIIB) and Sage Therapeutics (NASDAQ:SAGE) said the U.S. Food and Drug Administration (FDA) currently does not plan to hold an advisory committee meeting to discuss an application seeking approval of oral medicine zuranolone to treat major depressive disorder (MDD) and postpartum depression (PPD).

The companies had completed a rolling submission of the new drug application (NDA) to the FDA in December 2022.
The NDA was granted priority review by the FDA and the agency is expected to make a decision by Aug. 5.
Zuranolone is an investigational oral drug being evaluated as a 14-day, rapid-acting, once-daily, therapy for adults with MDD and PPD, according to the companies.