Key considerations for the FDA approval of zuranolone for postpartum depression treatment

Mixed-bag approval hit Sage hard but spared Biogen

Sage Therapeutics recently notched an FDA win for the neuroactive steroid zuranolone (Zurzavae) for postpartum depression (PPD). For major depressive disorder (MDD), however, the agency handed the drug a complete response letter. In the wake of the news, Sage’s stock is down 46% to $19.52, while BIIB, which jointly developed the drug, ticked up slightly to $270.34 over the past five trading days.

Sage’s zuranolone partnership with Biogen may soften the blow, said Emma Wille, healthcare analyst for Citeline. But it’s clear that the MDD failure was “a hit,” she noted. “MDD is a huge market, and a lot of key opinion leaders were very interested in this drug because of its novel mechanism and a short course,” Wille said, referring to its 15-day course of administration.

Zuranolone is now the newest rapid-acting option for a mood disorder

Traditionally, patients newly prescr…

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