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Organon Announces Interim Results of 6-Year MIUDELLA Study

Organon announced that Sebela Women's Health will present interim results from an ongoing Phase 3 study evaluating MIUDELLA, a hormone-free, copper intrauterine device, through 6 years of use at the 2026 Society of Family Planning Annual Meeting, taking place October 17 to 19, 2026, in San Francisco, California. In June 2026, Organon exclusively licensed global rights to MIUDELLA from Sebela Women's Health. The prospective, single-arm Phase 3 study is being conducted by Sebela Women's Health at 42 sites in the United States to evaluate the efficacy and safety of MIUDELLA through 6 years of use. The 6-year outcomes were evaluated in 465 of 1397 and 592 of 1601 enrolled participants in the evaluable-for-pregnancy and safety populations, respectively. The cumulative 6-year Pearl Index was 0.93, and the cumulative Kaplan-Meier pregnancy rate was 3.9% at 6 years. Treatment-emergent adverse events reported through 6 years included heavy menstrual bleeding, dysmenorrhea and pelvic discomfort. Bleeding- and pain-related adverse events leading to study discontinuation were observed in 139 participants in year 1 and 11 participants in year 6.1 Follow-up in the study is ongoing. The U.S. Food and Drug Administration accepted for review a supplemental New Drug Application for MIUDELLA for an extended duration of use for up to 6 years, with Prescription Drug User Fee Act action expected in the second quarter of calendar year 2027.

Organon’s Miudella sNDA Accepted by FDA for Review

Organon announced the US Food and Drug Administration, FDA, has accepted for review Sebela Women's Health's supplemental New Drug Application, sNDA, for Miudella 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. "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."

Organon Presents VTAMA Study Results at Pediatric Dermatology Annual Meeting

Organon will present results from a post hoc analysis of pooled data from the Phase 3 pivotal trials, ADORING 1 and ADORING 2, evaluating the efficacy and safety of VTAMA cream versus vehicle today at the 2026 Society for Pediatric Dermatology Annual Meeting in Minneapolis, Minnesota. VTAMA cream is the first and only aryl hydrocarbon receptor agonist indicated for the treatment of both atopic dermatitis in adults and pediatric patients 2 years and older and plaque psoriasis in adults. In the ADORING 1 and ADORING 2 pivotal trials, adults and children 2 years and older with moderate to severe atopic dermatitis were randomized 2:1 to VTAMA cream or vehicle once daily for 8 weeks.