FDA approves zuranolone for postpartum depression but issues complete response letter for major depressive disorder

Zuranolone molecule image from PubChem

FDA’s approval of Zurzuvae for PPD could mark a significant shift in the fight against postpartum depression (PPD). On August 4, the agency gave the green light for the oral medication, although it declined its use for major depressive disorder (MDD), citing insufficient evidence of effectiveness.

The former approval represents a milestone as the first ever FDA-authorized oral medication specifically for PPD, a condition estimated to affect one in five new mothers. 

Still, the rejection for MDD, which affects more than 21 million American adults, sent Sage’s stock valuation reeling. In early afternoon trading, SAGE shares were down 52.24% to $17.24. In contrast, Biogen stock was up 0.47% to $270.19. 

Sage’s optimism for Zurzuvae in PPD treatmentt

In a business update call, CEO Barry Greene attempted to accentuate the positive. “We&#…

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