Organon Announces US FDA Has Accepted for Review a Supplemental New Drug Application for MIUDELLA®, a Hormone-Free Intrauterine Device
The FDA accepted for review Sebela Women's Health's supplemental New Drug Application for MIUDELLA, Organon's hormone-free copper intrauterine device, seeking to extend the approved duration of use from 3 to 6 years, with PDUFA action expected in the second quarter of 2027. Organon exclusively licensed global rights to MIUDELLA from Sebela in an agreement completed in June 2026, and the product is anticipated to be commercially available in late 2026. The filing is supported by a Phase 3 US trial in 1,904 women that showed the device to be approximately 99% effective, with a cumulative 3-year Pearl Index of 1.05.
Key figures
- Drug Name
- MIUDELLA (copper intrauterine system)
- Phase Of Trial
- Phase 3
- Efficacy
- 99%
- Pearl index 3year
- 1.05
- Pearl index year1
- 0.94
- Proposed duration
- 6 years
- Trial participants
- 1904
- Pdufa action timing
- Q2 2027
- Current approved duration
- 3 years
- Expected commercial availability
- late 2026
AI analysis
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