Organon reports six‑year MIUDELLA data as FDA reviews longer use

Six-year contraceptive results support a bid to double MIUDELLA's labelled duration as Organon & Co. NYSEOGN reported interim Phase 3 data on Friday. The hormone-free device remains approved for up to three years, with FDA action on longer use expected in the second quarter of 2027.

Sebela Women's Health, which is conducting the study, has submitted a supplemental New Drug Application seeking use for up to six years. Organon said on Sept. 14 that the FDA had accepted the application for review and that commercial availability under the existing label was anticipated in late 2026.

Organon is a Jersey City, N.J.-based global drugmaker with a broad portfolio spanning women's health, general medicines and biosimilars.

Organon shares closed at US$13.76, up 0.15 per cent, at 4 p.m. EDT on Oct. 15 in New York NYSEOGN. That close predates Friday's announcement and does not establish a response to the new data.

Six-Year Results Come From A Single-Arm Study

The prospective study spans 42 U.S. sites and enrolled women aged 17 to 45. Six-year outcomes were evaluated in 465 of 1,397 participants in the pregnancy-evaluable population. The corresponding safety population included 592 of 1,601 enrolled participants.

The cumulative Pearl Index was 0.93, with a 95 per cent confidence interval of 0.62 to 1.34. The index measures pregnancies per 100 women over a year of exposure. The cumulative Kaplan-Meier pregnancy rate was 3.9 per cent at six years, with a 95 per cent confidence interval of 2.7 to 5.8 per cent.

The original primary endpoint measured contraceptive efficacy through three years using the Pearl Index; Friday's figures are interim extension results. There was no control arm, so the findings do not establish superior efficacy or tolerability over another IUD.

Organon reported no new safety signals during extended follow-up, although treatment-emergent events through six years included heavy menstrual bleeding, painful periods and pelvic discomfort. Bleeding- and pain-related events led 139 participants, or 8.7 per cent, to discontinue in year one. In year six, 11 participants, or 1.9 per cent, discontinued for those reasons.

"The findings support the FDA review of the supplemental application as we work toward our ambition of expanding hormone-free contraceptive options," Organon chief medical officer Juan Camilo Arjona Ferreira said in the release.

Longer Use Would Narrow The Duration Gap

The listed peer is The Cooper Companies, Inc. NASDAQCOO through its CooperSurgical business. CooperSurgical's product information lists Paragard for up to 10 years of hormone-free contraception as of Oct. 16. Approval would narrow MIUDELLA's labelled duration gap without establishing a clinical advantage over Paragard.

Cooper's Sept. 9 results put CooperSurgical quarterly revenue at US$349.2 million, up 2 per cent, for the period ended July 31. That revenue includes the broader office, surgical and fertility businesses rather than Paragard alone.

For MIUDELLA, the FDA label revised in February 2025 requires removal or replacement after three years. It also carries a boxed warning about complications from improper insertion and requires provider training through a restricted Risk Evaluation and Mitigation Strategy programme.

Organon's Sept. 14 announcement said providers, healthcare settings and eligible specialty pharmacies could complete the required certification and enrolment activities.

Organon's April 30 results reported US$1.12 billion in cash and US$8.57 billion in debt at March 31. Those are historical balances; Friday's MIUDELLA announcement supplied no cash-runway estimate or product sales forecast.

Sebela will present the interim results on Oct. 17 at 6 p.m. PDT at the Society of Family Planning meeting in San Francisco. The next regulatory milestone is expected in the second quarter of 2027, when FDA action will determine whether MIUDELLA's approved duration extends to six years.