Biogen Inc. — Zurzuvae EMA EPAR public assessment report (EMEA/H/C/006488, 2026)
Biogen Inc. · 2026 · EMA EPAR public assessment report · company profile →
Report summary
The European Medicines Agency (EMA) has issued a positive opinion for the marketing authorization of Biogen's Zurzuvae (zuranolone) for treating postpartum depression (PPD) in adults. Zuranolone, a neuroactive steroid and GABAA receptor positive allosteric modulator, demonstrated rapid and sustained improvement in depressive symptoms in clinical trials, with a statistically significant reduction in HAMD-17 scores by Day 15. Common adverse events include somnolence, dizziness, and sedation, which are generally mild. Non-clinical studies highlighted sedation as a dose-limiting effect and noted some reproductive toxicities at higher exposures. The drug's pharmacokinetics are influenced by food and CYP3A inhibitors/inducers. While zuranolone impairs driving ability and has some abuse potential, its overall benefit-risk balance for PPD is considered favorable, leading to the recommendation for approval.
Key findings — cited to the page
| Relative infant dose of zuranolone in breast milk | 0.357 % | · p.58 |
| Relative infant dose of zuranolone in breast milk (Day 5) | 0.3566163 % | · p.58 |
| QTc effect at exposures vs clinical mean Cmax (50 mg) | 7.1 fold | · p.39 |
| Pulmonary function effects at exposures vs clinical mean Cmax (50 mg) | 3 fold | · p.39 |
| Relative infant dose of zuranolone in breast milk (Day 1) | 0.2174451 % | · p.58 |
| Maternal NOAEL for general toxicity | 1 mg/kg/day | · p.33 |
| NOAEL for growth and development in offspring | 1 mg/kg/day | · p.33 |
| PECsw, refined | 0.00166 µg/L | · p.37 |
| Log Kow | 4.3 | · p.37 |
| Fpen refined value | 0.00166 | · p.37 |
| hERG channel inhibition at 3 µM | 23 % | · p.39 |
| Relative infant dose of zuranolone in breast milk (Days 1 to 11) | 0.3140414 % | · p.58 |
Source: Biogen Inc. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →