FDA grants priority review for Sage’s rapid-acting treatment for depression

Sage Therapeutics said Monday that U.S. regulators accepted a marketing application for its rapid-acting antidepressant and granted it priority review with a decision date set for early August.

The Food and Drug Administration will assess the efficacy and safety of the Sage drug, a once-daily pill called zuranolone, for the treatment of people with major depressive disorder and postpartum depression.

Biogen owns half the commercial rights to zuranolone, for which it paid $1.5 billion to Sage in 2020.

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