FDA to Evaluate Miudella Copper IUS for Extended 6-Year Use
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Republished by Newlife - MIM. All rights belong to the original publisher; see Source below.
A regulatory decision on the extended duration is expected in the second quarter of 2027.
The Food and Drug Administration (FDA) has accepted for review the supplement New Drug Application for Miudella ® (copper intrauterine system), seeking to extend the duration of use from 3 years to up to 6 years.
Miudella is a copper-containing intrauterine system (IUS) indicated for the prevention of pregnancy in females of reproductive potential. It was approved in February 2025 based on data from a single-arm, open-label study (ClinicalTrials.gov Identifier: NCT03633799 ) that included 1601 women who had Miudella successfully placed.
The primary endpoint was contraceptive efficacy through 3 years of use, as measured by the Pearl Index (PI). Findings showed the cumulative 3-year PI was 1.05 (95% CI, 0.66-1.60) in a cohort of women aged 17 to 35 years (N=1397).
The study protocol includes an extension phase assessing Miudella for up to 8 years. The sNDA submission for a 6-year duration is based on the accumulated long-term data from this ongoing study.
The most common adverse reactions with Miudella include heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, postprocedural hemorrhage, and dyspareunia.
“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 6 years of hormone-free contraception and the potential to expand a woman’s contraceptive choices.”
According to the Company, Miudella will be commercially available in late 2026. A regulatory decision on whether the duration of use can be extended to 6 years is expected in the second quarter of 2027.
Because of the risk of complications from improper insertion, Miudella is only available through a restricted program called the Miudella REMS . The program ensures that health care providers are trained on proper insertion before the first use.
Miudella is supplied as a copper-containing sterile IUS preloaded in a single use inserter. The IUS consists of a nitinol frame with 10 copper sleeves attached to provide a copper surface of 175mm 2 and a monofilament polymer retrieval thread tied to the vertical arm.
Source
- empr.com (2026-09-14) - Original article: FDA to Evaluate Miudella Copper IUS for Extended 6-Year Use - MPR - https://empr.com/news/fda-accepts-snda-miudella-ius-extended-duration