Sage, Biogen submit NDA for depression treatment

Pharmaceutical company Sage Therapeutics and biotech firm Biogen announced completion of a rolling submission of a new drug application to the FDA for zuranolone for the treatment of major depressive disorder and postpartum depression.

Zuranolone showed sustained and rapid improvement of depressive symptoms in the clinical development program to date and is being evaluated as a rapid-acting, once-daily, 14-day oral short course treatment in adults with MDD and PPD, the companies said in a press release.

Zuranolone may help to rapidly rebalance dysregulated neuronal networks to restore brain function in people with depression, according to the press release. The new drug targets brain networks responsible for functions such as mood, arousal, behavior and cognition.

“Based on the data in the LANDSCAPE and NEST programs, we believe that zuranolone has the potential to be a meaningful new therapy for depression,” Priya Singhal, MD, MPH, head of global safety and regulatory sciences and interim head of research and development at Biogen, said in the release. “We look forward to working with the FDA as this filing progresses.”

“We need to rethink how MDD and PPD are treated,” Sage chief medical officer Laura Gault, MD, PhD, said in the release. “Existing treatments often take weeks to months to provide symptom relief, and patients may need to cycle through multiple treatment options to fully address their symptoms. We believe that zuranolone, if approved, could evolve the way depression is treated, and this submission brings us one step closer to that goal.”