FDA accepts extended duration sNDA for MIUDELLA IUD

The FDA has accepted for review a supplemental New Drug Application (sNDA) filed by Sebela Women’s Health for MIUDELLA (copper intrauterine system; Organon) for an extended duration of use of up to 6 year. A Prescription Drug User Fee Act (PDUFA) action date expected in the second quarter of 2027, Organon announced in a news release published on September 14, 2026.

MIUDELLA is a hormone-free, copper intrauterine device (IUD) currently indicated for the prevention of pregnancy in females of reproductive potential for up to 3 years. It is the first hormone-free IUD to be introduced in the US in over 40 years, having received initial FDA approval on February 24, 2025. Organon completed its agreement to exclusively license global rights to MIUDELLA from Sebela Pharmaceuticals in June 2026, and the device is anticipated to be commercially available in late 2026.

“If approved, MIUDELLA would offer up to [6] years of hormone-free contraception and the potential to expand a woman’s contraceptive choices,” said Juan Camilo Arjona Ferreira, MD, Head of Research and Development and Chief Medical Officer at Organon.

What did the phase 3 clinical program show?

MIUDELLA was investigated in 3 clinical trials in the United States in 1904 women aged 17 to 45 years. The phase 3 prospective, multicenter, single-arm, open-label study (NCT03633799) was conducted at 42 centers in the United States.

“We calculated the Pearl Index (pregnancies/100 person-years) through 3 years as the primary efficacy outcome,” wrote the authors in Contraception, where study results were published.²

“The secondary outcomes included pregnancy percentages by life-table analysis, placement success, safety (adverse events), and tolerability,” they wrote.

In the efficacy cohort of women aged 17 to 35 years (n = 1397), the first-year Pearl Index was 0.94 (95% CI, 0.43–1.78) and the cumulative 3-year Pearl Index was 1.05 (95% CI, 0.66–1.60). According to Organon, the IUD had an overall placement success rate of approximately 99%. The most common adverse reactions reported in 5% or more of participants were heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post-procedural hemorrhage, and dyspareunia.¹

In the first year, 8.5% of participants across all 3 studies discontinued due to bleeding or pain adverse events, a rate that decreased to 3.2% by year 3. Expulsion rates ranged from 1.9% in year 1 to 0.9% in year 3.¹

According to study authors, 1- and 3-year continuation rates were 78.9% and 49.6%, respectively.²

“Women deserve contraceptive options that reflect their individual needs and preferences,” said Kelly Culwell, MD, Chief Medical Officer and Head of Research and Development at Sebela Women’s Health. “FDA’s acceptance for review of this supplemental application reflects the dedication of the investigators and more than 1900 women who participated in Miudella’s clinical trials.”¹

What are the key safety considerations and REMS requirements?

MIUDELLA carries a boxed warning for risk of complications due to improper insertion, which may increase the risk of perforation, infection, undiagnosed abnormal bleeding, pregnancy loss, and expulsion. The device is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Health care providers must be certified through the MIUDELLA REMS program prior to first use. Additionally, pharmacies and healthcare settings dispensing MIUDELLA must also be certified.

MIUDELLA is contraindicated in pregnancy or suspected pregnancy, congenital or acquired uterine abnormalities distorting the uterine cavity, acute pelvic inflammatory disease, postpartum or postabortal endometritis within the past 3 months, and more.

See the full list of contraindications by viewing MIUDELLA’s full prescribing information at the Sebela website.³

References:

1. Organon announces US FDA has accepted for review a supplemental new drug application for MIUDELLA, a hormone-free intrauterine device. Organon. News release. Published September 14, 2026. Accessed September 14, 2026. https://organon2021tf.q4web.com/news/news-details/2026/Organon-Announces-US-FDA-Has-Accepted-for-Review-a-Supplemental-New-Drug-Application-for-MIUDELLA-a-Hormone-Free-Intrauterine-Device
2. Creinin MD, Gawron LM, Roe AH, et al. Three-year efficacy, safety, and tolerability outcomes from a phase 3 study of a low-dose copper intrauterine device. Contraception. 2025;143:110771. doi:10.1016/j.contraception.2024.110771
3. Highlights of prescribing information. Sebela Pharma. Accessed September 14, 2026. https://sebelapharma.com/assets/media/miudella-PI.pdf