Aug. 4 Quick Takes: Sage-Biogen get FDA approval for one of two depression indications
Plus: Galapagos trims Jyseleca guidance, seeks options; and updates from Mesoblast, Lilly, Sino and more
FDA approved Zurzuvae zuranolone from Biogen Inc. (NASDAQ:BIIB) and Sage Therapeutics Inc. (NASDAQ:SAGE) to treat postpartum depression, but the agency issued a complete response for the second indication it was reviewing, major depressive disorder. Biogen said FDA wants “an additional study or studies” for MDD because the application “did not provide substantial evidence of effectiveness to support approval” in the indication.
Biogen is counting on sales of the drug to help offset the sagging revenues of its multiple sclerosis franchise. If it does not eventually receive approval for MDD, its commercial potential may be limited. Zurzuvae’s acute, two-week course of the therapy could be attractive to patients, but could also be a factor that limits revenue in an indication where most therapies are dosed chronically. ...