The clinical trials are completed, a new drug application has been accepted, and the US Food and Drug Administration has set a 5 August action date for deciding whether to approve Sage Therapeutics, Inc.’s zuranolone for major depressive disorder (MDD) and postpartum depression (PPD). And while checking those tasks off its to-do list with partner Biogen, Inc., the companies have been working on a commercial strategy they are eager to roll out around the end of the year that will require a new way of thinking about how to treat depression.
Even with a summertime approval, if all goes to plan, it will be late 2023 before zuranolone is available for...