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Organon Reports Positive Six-Year Phase 3 Data for Hormone-Free IUD MiuDella

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OGN$13.76 0.15%

Organon & Co. (NYSE:OGN) announced positive interim Phase 3 study results evaluating its hormone-free copper intrauterine device, MIUDELLA, through six years of use. The prospective U.S. study demonstrated a cumulative six-year Pearl Index of 0.93 and a cumulative pregnancy rate of 3.9%. Discontinuations due to bleeding and pain fell from 8.7% in the first year to 1.9% in the sixth year.

The findings strengthen the long-term clinical profile for MIUDELLA, which Organon licensed exclusively from Sebela Women's Health in June 2026. The device is currently approved to prevent pregnancy for up to three years. Showing sustained contraceptive effectiveness and declining adverse event rates over six years supports efforts to provide extended non-hormonal birth control options to patients.

The U.S. Food and Drug Administration has accepted a supplemental New Drug Application to extend MIUDELLA's approved duration of use to six years. A regulatory decision under the Prescription Drug User Fee Act is expected in the second quarter of 2027, while patient follow-up in the ongoing study continues.

Key points

  • Organon reported interim Phase 3 trial results showing MIUDELLA maintained a 3.9% cumulative pregnancy rate through six years of use.
  • Study discontinuations caused by pain and bleeding decreased from 8.7% in year one down to 1.9% in year six.
  • The U.S. FDA is reviewing a supplemental New Drug Application to extend MIUDELLA's approved label from three years to six years.
  • A regulatory decision under PDUFA guidelines is anticipated in the second quarter of 2027.

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Questions and answers

What were the key six-year Phase 3 trial results for MIUDELLA?

The study showed a cumulative six-year Pearl Index of 0.93 and a cumulative pregnancy rate of 3.9%. Discontinuations from pain or bleeding dropped from 8.7% in year one to 1.9% in year six.

When will the FDA decide on extending MIUDELLA's approval to six years?

The FDA accepted a supplemental New Drug Application for review, with a Prescription Drug User Fee Act action expected in the second quarter of 2027.

What is MIUDELLA currently approved for?

MIUDELLA is currently approved as a hormone-free, low-dose copper intrauterine device to prevent pregnancy in females of reproductive potential for up to three years.