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Organon Announces US FDA Has Accepted for Review a Supplemental New Drug Application for MIUDELLA®, a Hormone-Free Intrauterine Device

OGN
  • Organon announced that the FDA has accepted Sebela Women's Health's supplemental New Drug Application (sNDA) to extend the approved duration of use for MIUDELLA® (copper intrauterine system) from 3 to 6 years.
  • The Prescription Drug User Fee Act (PDUFA) action date for the sNDA is expected in the second quarter of calendar year 2027.
  • Organon completed an agreement in June 2026 to exclusively license global rights to Sebela's MIUDELLA, which is currently indicated for pregnancy prevention for up to 3 years.
  • MIUDELLA is a hormone-free copper IUD anticipated to be commercially available in late 2026.
  • The product is subject to a Risk Evaluation and Mitigation Strategy (REMS) to ensure healthcare providers are trained in proper insertion to mitigate complications from improper placement.
  • Clinical trials involving 1,904 women demonstrated a 99% effectiveness rate with a cumulative 3-year Pearl Index of 1.05.
  • Most common adverse reactions (≥5%) included heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post-procedural hemorrhage, and dyspareunia.
  • MIUDELLA is contraindicated for individuals with Wilson's disease due to the copper component, as well as for those with pregnancy, uterine abnormalities, acute pelvic inflammatory disease, or hypersensitivity to device materials.
  • The REMS program requires certification for healthcare providers, pharmacies, and healthcare settings that dispense or insert the device.
  • Organon expects the 6-year approval to expand contraceptive choices by offering long-term, hormone-free birth control options.