Biogen and Sage Therapeutics’ race to bring depression drug zuranolone to market is entering the home stretch. After talking to the FDA, the partners have outlined plans to start a rolling submission early in 2022 and complete the filing in the second half of the year.
Zuranolone was on the ropes late in 2019, when the failure of a phase 3 trial in major depressive disorder raised fears that the GABA-A receptor positive allosteric modulator would never make it to market. Sage responded by overhauling its clinical trial strategy, betting that three short-term studies would enable it to seek approval in multiple indications. Biogen later came on board.
Roughly 18 months after embarking on the new strategy, Sage has emerged from pre-NDA talks with the FDA convinced it already has the safety and efficacy data needed to seek approval of zuranolone.
“In the pre-NDA meeting, the FDA’s response on the regulatory pathway for zuranolone continued to be consistent with previous discussions. We believe we have a solid filing package with four adequate and well controlled trials now in hand and, if approved, zuranolone will fill a real unmet need,” Sage CEO Barry Greene said in a statement.
The partners will first apply for approval in major depressive disorder (MDD). A filing for approval in postpartum depression (PPD) is set to follow in 2023. Sage and Biogen are holding off on seeking approval in PPD until after the completion of the PPD 301-SKYLARK trial “so as not to affect the MDD review timeline,” adding that “the review cycles may allow commercialization of both indications simultaneously.”
Sage and Biogen are still working to wrap up the CORAL study that is testing zuranolone 50 mg in patients with MDD. The partners had previously expected the clinical trial to read out by the end of the year. That target slipped to early 2022 in the latest update.