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

Sebela's sNDA Seeks to Extend Approved Duration of Use from 3 to 6 Years

JERSEY CITY, N.J., September 14, 2026--Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, today announced the US Food and Drug Administration (FDA) has accepted for review Sebela Women's Health's supplemental New Drug Application (sNDA) for MIUDELLA® (copper intrauterine system) for an extended duration of use for up to 6 years with Prescription Drug User Fee Act (PDUFA) action expected in the second quarter of calendar year 2027.

In June of 2026, Organon completed its agreement to exclusively license global rights to Sebela's MIUDELLA. MIUDELLA is a hormone-free, copper intrauterine device (IUD) indicated for the prevention of pregnancy in females of reproductive potential for up to 3 years and is anticipated to be commercially available in late 2026.

The MIUDELLA label includes a Risk Evaluation and Mitigation Strategy (REMS), which is open for enrollment at www.miudellarems.com. The website enables healthcare providers, healthcare settings, and eligible specialty pharmacies to complete the certification and enrollment activities required to support the dispensing and insertion of MIUDELLA. The purpose of the MIUDELLA REMS is to mitigate the risk of complications due to the improper insertion of MIUDELLA by untrained healthcare providers. Please see Important Safety Information below including Boxed Warning.

"The FDA's acceptance for review of this supplemental application represents an important milestone as we work to broaden birth control options for women," said Juan Camilo Arjona Ferreira, MD, Head of Research & Development and Chief Medical Officer at Organon. "If approved, MIUDELLA would offer up to six years of hormone-free contraception and the potential to expand a woman's contraceptive choices."

"Women deserve contraceptive options that reflect their individual needs and preferences," stated 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 1,900 women who participated in Miudella's clinical trials. We look forward to working with Organon to expand access to Miudella."

About MIUDELLA

MIUDELLA was investigated in three clinical trials in the US in 1,904 women aged 17 to 45 years. The Phase 3 prospective, multicenter, single-arm, open-label study was conducted in 42 centers in the US with a primary endpoint of contraceptive efficacy through 3 years of use as assessed by the Pearl Index (defined as the number of pregnancies per 100 women over one year).1 In the efficacy cohort of women aged 17 to 35 years from the Phase 3 study (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)—in other words, 99% effective, with an overall placement success rate of ~99%. The most common adverse reactions (≥5%) observed in clinical trials were heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post-procedural hemorrhage, and dyspareunia. In the first year, 8.5% of participants across all three studies discontinued treatment due to bleeding or pain adverse events, which decreased to 3.2% by year 3. Expulsion rates ranged from 1.9% in year 1 to 0.9% in year 3.