Biogen receives European Commission approval for Zurzuvae (zuranolone), the first and only treatment approved for women with postpartum depression in Europe

Biogen

17 September 2025 - The EC approval of Zurzuvae is based on the SKYLARK study, which demonstrated rapid relief from depressive symptoms as early as day 3 and sustained through day 45 compared to placebo.

Biogen announced that the European Commission has granted marketing authorisation for Zurzuvae (zuranolone) to treat post-partum depression in adults following childbirth.

Read Biogen press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , Europe , Registration