EC nod for Biogen’s PPD drug Zurzuvae

18 September 2025

The European Commission (EC) has granted marketing authorization for US biotech major Biogen’s (Nasdaq: BIIB) Zurzuvae (zuranolone) to treat post-partum depression (PPD) in adults following childbirth.

Zurzuvae is a once-daily, oral, 14-day treatment which represents a novel therapeutic approach, offering the first and only treatment indicated for PPD in the European Union (EU).

Zurzuvae was approved and launched in the USA at end 2023 and generated sales of $74.1 million in second-quarter 2025, up 171% year-on-year, for the company. In August 2025, Zurzuvae received regulatory approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

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