Sage, Biogen set their sights on a summer PDUFA deadline as zuranolone decision looms
Sage and its partners at Biogen can now mark a summer date for a go/no go marketing decision for their blockbuster depression candidate, zuranolone. The FDA has put the fast-acting anti-depressive on the inside regulatory track, offering a quick priority review and setting the PDUFA for Aug. 5.
That’s a solid piece of good news for the developers, but Brian Abrahams at RBC notes some major hurdles ahead. The biggest immediate one: the prospect of an expert panel review, which he thinks ought to be made clear in the next couple of weeks. And that raises the possibility of some nasty surprises, followed by a tough marketing challenge.
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