Sage Therapeutics and Biogen Inc. announced they have initiated a rolling submission for a New Drug Application to the FDA for zuranolone, a once-daily oral drug being developed to treat major depressive disorder.
The companies stated they have submitted the nonclinical module of the NDA and plan to submit the remaining portions in the second half of the year. Remaining information will include completed studies of zuranolone from the LANDSCAPE and NEST clinical development programs, which include data from the ongoing open-label SHORELINE study, as well as data from completed clinical