The US Food and Drug Administration has accepted for review a supplemental New Drug Application from Sebela Women's Health for MIUDELLA, the hormone-free copper intrauterine system, seeking to extend its approved duration of use from 3 to 6 years, Organon announced. Organon, which in June of 2026 completed an agreement to exclusively license global rights to MIUDELLA, said a Prescription Drug User Fee Act action on the application is expected in the second quarter of calendar year 2027. MIUDELLA is currently 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 product was investigated in three US clinical trials in 1,904 women aged 17 to 45 years; in the Phase 3 efficacy cohort of women aged 17 to 35 years, the first-year Pearl Index was 0.94 and the cumulative 3-year Pearl Index was 1.05, with an overall placement success rate of about 99 percent. Juan Camilo Arjona Ferreira, Head of Research and Development and Chief Medical Officer at Organon, called the acceptance an important milestone, and Kelly Culwell, Chief Medical Officer and Head of Research and Development at Sebela Women's Health, noted that more than 1,900 women participated in Miudella's clinical trials.
Organon & CoFDA accepted for review the sNDA seeking to extend MIUDELLA's approved use from 3 to 6 years, a regulatory milestone for Organon's exclusively licensed product.
FDA accepted Sebela Women's Health's sNDA seeking to extend MIUDELLA's duration of use from 3 to 6 years.
