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Biogen’s ZURZUVAE® Receives EU Approval for Postpartum Depression

9/18/2025

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Summary

Story summary

Biogen gained European Commission approval for ZURZUVAE® (zuranolone) to treat postpartum depression (PPD) in adults.
This 14-day oral treatment is the first specifically approved for PPD in the E.U.
PPD affects up to 20% of new mothers in Europe, highlighting a significant unmet need.
The SKYLARK study indicated ZURZUVAE reduced depressive symptoms by day 3.
Side effects include somnolence, dizziness, and sedation in over 5% of patients.

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Story summary

Biogen gained European Commission approval for ZURZUVAE® (zuranolone) to treat postpartum depression (PPD) in adults.
This 14-day oral treatment is the first specifically approved for PPD in the E.U.
PPD affects up to 20% of new mothers in Europe, highlighting a significant unmet need.
The SKYLARK study indicated ZURZUVAE reduced depressive symptoms by day 3.
Side effects include somnolence, dizziness, and sedation in over 5% of patients.