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.
advertisement
“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.
Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!
GET STARTED Log In
Previous article：
Medicare details structure of new drug price negotiation program
Next article： Heart attack and stroke risk calculators need revising
Next article： Heart attack and stroke risk calculators need revising
