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.