Prognosis
Sage Tumbles as FDA Narrows Depression Pill’s Approval
- FDA clears Zurzuvae treatment only for postpartum depression
- Drug approved with boxed warning for driving, other activities
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Sage Therapeutics Inc. shares hit a record low after regulators granted approval to its fast-acting pill only for postpartum depression, denying the drug clearance for major depressive disorder.
The Food and Drug Administration approved the drug, Zurzuvae, late Friday with a boxed warning that it may affect patients’ ability to drive or operate heavy machinery, and they should avoid doing so for 12 hours after taking it. The agency also told Sage that it lacked the data to show it works in MDD, and more research will be needed.