The U.S. regulatory agency was previously slated to decide whether or not to approve the drug as a treatment for postpartum depression by Dec. 19.
The Cambridge, Mass.-based company noted that the FDA elected to extend the PDUFA goal date by three months to make time for the submission of a REMS program that was not submitted in the original application. Sage added that the FDA has not requested additional clinical data as part of the extension.
“Our primary goal remains bringing treatment to women suffering from PPD as quickly as possible. In light of this unexpected delay, we will work diligently with the FDA to ensure that the unmet medical need of women suffering with PPD can be addressed expeditiously,” CEO Dr. Jeff Jonas said in prepared remarks.
In November this year, the FDA’s Psychopharmacologic Drugs advisory committee and Drug Safety and Risk Management advisory committee voted 17-1 that data support a favorable benefit-risk profile of Zulresso for the treatment of PPD. The drug is the first under review at the FDA that is specifically designed to treat PPD.
SAGE shares were trading at $105.50 apiece in premarket activity today, down -3.8%.
*Article updated to clarify that Sage’s drug is not an injectable product, but rather an infusion.