FDA Approves Zurzuvae, first drug post-partum depression, but not for MDD
Friday produced a mixed decision from the US Food and Drug Administration (FDA) for biotechs Sage Therapeutics (Nasdaq: SAGE) and its partner Biogen (Nasdaq: BIIB) regarding their new type of antidepressant. Neither company’s shares were impacted to any meaningful degree.
The FDA approved zuranolone 50mg, to be marketed under the brand name Zurzuvae, for adults with postpartum depression (PPD), making it the first and only oral, once-daily, 14-day treatment that can provide rapid improvements in depressive symptoms for women with PPD.
Zurzuvae is expected to launch and be commercially available in the fourth quarter of 2023 shortly, following scheduling as a controlled substance by the US Drug Enforcement Administration, which is anticipated to occur within 90 days.
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