Shots:
- The CHMP has recommended Zurzuvae (zuranolone) for the treatment of postpartum depression in adults; EC’s decision is expected in Q3’25
- Approval was based on P-III (SKYLARK) trial assessing Zurzuvae (50mg) vs PBO in pts with severe postpartum depression
- Trial met its 1EP with a significant mean reduction in HAMD-17 total score at Day 15, & all key 2EP, which showed a rapid reduction in depressive symptoms by Day 3, sustained through Day 45
Ref: Biogen| Image: Biogen | Press Release
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