FDA proposes changes to key medical devices approval pathway

Sage Therapeutics said Monday that it may need to reduce costs, including through employee layoffs, following the Food and Drug Administration’s denial of its rapid-acting drug for major depressive disorder.

On Friday, the agency granted market clearance for the drug, called Zurzuvae, to treat women with postpartum depression, a smaller commercial market. Sage failed to convince regulators to also approve the drug for depression, a broader condition.

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“We don’t agree with the FDA review,” Sage CEO Barry Greene said during an earnings call, a point he made repeatedly. “We are evaluating the [FDA’s response letter] and as soon as we can provide more clarity, we will, on what the next steps are.

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