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Biogen, Sage plot 2022 filing for zuranolone approval, furthering turnaround of depression drug

October 19, 2021


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.

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