Sage Therapeutics (Nasdaq:SAGE) and Biogen (Nasdaq: BIIB) have begun a rolling submission of a New Drug Application (NDA) to FDA for zuranolone to treat major depressive disorder (MDD).
The two companies plan on submitting additional clinical data for the NDA in the second half of the year.
Biogen entered into a $1.5 billion licensing agreement with Sage Therapeutics to commercialize zuranolone (SAGE-217) and SAGE-324 in late 2020.
Zuranolone is an oral neuroactive steroid GABA-A receptor positive allosteric modulator (PAM).
In Phase 3 clinical trials, zuranolone 50 mg is administered daily for 14 days.
In addition to MDD, Sage and Biogen plan on pursuing approval for zuranolone in PPD starting next year.
The drug candidate won Fast Track Designation from the FDA in 2017 in MDD and Breakthrough Therapy Designation a year later.
Data were positive from the LANDSCAPE and NEST clinical trial programs.
“Zuranolone has the potential to help address a significant unmet medical need in depression as an innovative option in a therapeutic area where little has changed in the past 30 years,” said Dr. Priya Singhal, head of global safety and regulatory sciences and interim head of R&D at Biogen, in a statement.
While the drug candidate appears to have a rapid therapeutic effect, questions remain about the durability of the drug’s antidepressant effect, as a February Reuters article observed.
The SHORELINE trial, which is part of the LANDSCAPE clinical program, is assessing the need for repeat dosing for up to 12 months.