Rolling submission is initiated of NDA to the FDA for zuranolone for the potential treatment of major depressive disorder.
Sage Therapeutics, Inc. and Biogen Inc. initiated a rolling submission of a New Drug Application (NDA) to the FDA for zuranolone in the treatment of major depressive disorder (MDD).
Zuranolone is an investigational two-week, once-daily oral drug being developed for MDD and postpartum depression (PPD).
The companies have submitted the nonclinical module of the NDA to the FDA and plan to submit the remaining components for the MDD filing in the second half of 2022.
Data from the completed studies of zuranolone in the LANDSCAPE and NEST clinical development programs, including data from the ongoing open-label SHORELINE Study in MDD, as well as data from the completed clinical pharmacology studies, will comprise the full submission package. The rolling submission process allows completed sections of an NDA to be submitted to the FDA for review on an ongoing basis.
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