The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Liletta® (levonorgestrel-releasing intrauterine system), extending the duration of use for up to 8 years of pregnancy prevention. Previously, the intrauterine device was indicated for contraception for up to 6 years.
Liletta contains 52mg of levonorgestrel, which initially releases at a rate of approximately 20mcg/day. This rate decreases progressively to approximately 6.5mcg/day after 8 years. By the end of the 8th year, Liletta should be removed and replaced at the time of removal with a new system if continued use is desired.
The approval was based on additional efficacy data from the multicenter, randomized, open-label phase 3 ACCESS IUS trial (ClinicalTrials.gov Identifier: NCT00995150), which evaluated Liletta in women 16 to 45 years of age. The primary endpoint was the pregnancy rate calculated as the Pearl Index (PI). For year 7 and 8, patients who were older than 39 years of age at the start of each year were excluded from the efficacy analysis.
Results showed that the PI for the 7th year of use was 0.49 (95% CI, 0.06-1.78) based on 5280 evaluable cycles and 2 pregnancies that occurred. For the 8th year of use, the PI was 0.00 (95% CI, 0.00-1.31) based on 3657 evaluable cycles and no pregnancies. The cumulative 2-year pregnancy rate for years 7 and 8 was 1.37 (95% CI, 0.71-2.62). Among 244 patients who desired pregnancy after study discontinuation, 63.1% conceived within 6 months after removal of Liletta and 83.2% conceived within 12 months after removal.
“Now more than ever, patients need access to safe, long-acting, and reversible contraceptive options,” said study investigator Dr Courtney Schreiber, Professor and Chief of Family Planning, Department of Obstetrics and Gynecology, Penn Medicine. “Liletta is the only hormonal IUD approved for 8 years with a single continuous study for the full duration, providing data for patients and clinicians on the outcomes (high efficacy, low rates of adverse events) with long-term continuous use.”
- FDA approves Medicines360’s Liletta® (levonorgestrel-releasing intrauterine system) 52 mg to prevent pregnancy for up to eight years. News release. Medicines360. Accessed November 14, 2022. https://www.prnewswire.com/news-releases/fda-approves-medicines360s-liletta-levonorgestrel-releasing-intrauterine-system-52-mg-to-prevent-pregnancy-for-up-to-eight-years-301676741.html
- Creinin MD, Schreiber CA, Turok DK, et al. Levonorgestrel 52 mg intrauterine system efficacy and safety through 8 years of use. Published online May 12, 2022. American Journal of Obstetrics & Gynecology. doi.org/10.1016/j.ajog.2022.05.022.
- Liletta. Package insert. Medicines360; 2022. Accessed November 14, 2022. https://www.rxabbvie.com/pdf/liletta_pi.pdf
This article originally appeared on MPR