Millions of parents in Europe who suffer from postpartum depression will now have access to a pharmaceutical treatment, following the European Commission (EC)’s approval of Biogen’s Zurzuvae (zuranolone).
Zurzuvae, taken orally once per day over two weeks, becomes the first and only treatment indicated for postpartum depression in the European Union (EU).
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Postpartum, also known as postnatal, depression is one of the most common medical conditions associated with pregnancy, with around 20% of women who have had a recent pregnancy experiencing symptoms associated with the mood disorder.
Affecting both mothers and fathers, parents may have depressed mood and anxiety, along with experiencing disruption to daily activities. Feelings of guilt and worthlessness can also lead to difficulty building a bond with the newborn.
Biogen’s Zurzuvae is approved for treating postpartum depression in adults following childbirth, meaning both new mothers and fathers will be eligible for the pill.
The medication is now the first treatment in Europe specifically approved for postpartum depression. Existing pharma-based options involved broadly approved antidepressants, along with talking therapy and digital therapeutics.
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By GlobalDataEurope follows the US and UK in approving the therapy. The US Food and Drug Administration (FDA) approved Zurzuvae in August 2023, while the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved the drug in August 2025.
Last year, Biogen’s CEO Chris Viehbacher said the launch in the US was “well above expectations”. The company, more well-known for co-developing Alzheimer’s treatment Leqembi (lecanemab), has not specifically issued a sales prediction for Zurzuvae. Analysis by GlobalData forecasts sales of $428m by 2031.
GlobalData is the parent company of Pharmaceutical Technology.
Zurzuvae improves postpartum depression by acting on GABA-A receptors, proteins involved in chemical pathways that modulate mood in the brain.
The Phase III SKYLARK study (NCT04442503) showcased Zurzuvae’s ability to reduce depression score on a commonly used rating scale. Symptoms approved as early as day three and effects were sustained up to 45 days, compared to placebo. The most common side effects were drowsiness, dizziness, and sedation.
“This 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,” said Priya Singhal, head of development at Biogen.
Zurzuvae was discovered by Sage Therapeutics, with Biogen entering a US co-development and commercialisation partnership with the company in 2020. As part of the deal, Biogen gained rights to develop and commercialise the drug outside the US, excluding three countries in Asia. Biogen attempted to buy Sage in January this year, although the neuroscience specialist’s takeover offer of $469m was rejected. Biopharma Supernus Pharmaceuticals then swopped in in June, agreeing to acquire Sage for $795m.
