Sage, Biogen zuranolone OKd for postpartum, but not major, depression
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Editor's note: This article was updated on Aug. 5 at 1245p ET to reflect the drug's availability and a FDA Complete Response Letter.
The US FDA has approved Sage Therapeutics' (NASDAQ:SAGE) and Biogen's (NASDAQ:BIIB) Zurzuvae (zuranolone), the first oral treatment for postpartum depression (PPD).
However, the two companies were dealt a blow as the agency separately issued a Complete Response Letter for the drug as a treatment for major depressive disorder (MDD), a much larger market.
The letter indicated that effectiveness data was lacking to support approval of zuranolone for MDD, adding the need for an additional trial or trials.
The PPD approval was supported by two double-blind, placebo-controlled studies showing treatment with zuranolone improved depression much more significantly than those on placebo.
Zurzuvae (zuranolone) is taken daily for 14 days. The companies anticipate availability of the drug for PPD in Q4.
Prior to Friday's approval, the only approved treatment for PPD was via IV injection.
In November 2020, Biogen (BIIB) brokered an agreement to co-develop zuranolone (SAGE-217) for MDD and PPD with Sage (SAGE). At the time, Sage (SAGE) received an upfront payment of $1.525B and is eligible for ~$1.6B in milestone payments.
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