Biogen wins European first for depression drug Zurzuvae
Posted: 19 September 2025 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
The medicine becomes the first EU-approved oral treatment for adults who have postpartum depression (PPD).
The European Commission (EC) has authorised Biogen’s Zurzuvae (zuranolone) for women with post-partum depression (PPD), making it the first oral treatment for the condition to be licensed in Europe.
The pill’s approval provides an important shift in the treatment landscape for the condition as an IV injection was previously the only available option.
Dr Priya Singhal, Head of Development at Biogen, remarked that the new approval “is a major milestone in addressing a critical unmet need in maternal health for women in Europe, where postpartum depression is underdiagnosed and undertreated”.
[Zurzuvae] can improve the symptoms of [postpartum depression] as early as day three. This is a significant step forward from the current standards of care…”
She explained that the treatment “can improve the symptoms of PPD as early as day three. This is a significant step forward from the current standards of care…” This outcome was maintained through day 45 compared to placebo, according to data from the SKYLARK study, part of the NEST clinical development programme, which the EC’s approval of Zurzuvae is based.
The once-daily, oral, 14-day medicine is a neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM).
According to Dr Kristina Deligiannidis, research suggests that PPD is in part caused by a disruption in the normal interaction between the nervous system’s stress response, ɣ-aminobutyric acid (GABA) signalling, and neuroactive steroids (NAS).
Bringing Zurzuvae to market
Zurzuvae won approval in August 2023 from the US Food and Drug Administration (FDA) and last month the Medicines and Healthcare products Regulatory Agency (MHRA) authorised the drug in the UK.
The treatment was originally discovered by Sage Therapeutics and in 2020 Biogen gained rights to develop and commercialise it outside of the US, excluding Japan, Taiwan and South Korea. Supernus Pharmaceuticals is Biogen’s collaboration partner in the US following completion of its acquisition of Sage Therapeutics.
Phase III study findings from 2022 have also showed the drug’s potential for addressing symptoms in major depressive disorder (MDD).
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