Sage and Biogen Begin Rolling Review Submission NDA to the FDA for Depression Drug

Sage Therapeutics and Biogen have begun a rolling submission of a New Drug Application (NDA) to the FDA for their investigational drug zuranolone for treatment of patients with major depressive disorder (MDD).

For the rolling review, the FDA will receive key components of the NDA ahead of time to shorten the review time and help resolve any issues sooner.

The submitted data include the results of several studies that demonstrated “rapid and sustained effects and a well-tolerated safety profile” of zuranolone in participants with MDD, the companies said.

The partners expect to complete their rolling submission later this year. They also plan to submit an NDA for zuranolone for treatment of postpartum depression in 2023.