Liletta approved to prevent pregnancy for up to 8 years
The Food and Drug Administration (FDA) has approved the Supplemental New Drug Application (sNDA) for Liletta® (Levonorgestrel-releasing intrauterine system), extension of the duration of use up to 8 years of pregnancy prevention. Previously, the intrauterine device was indicated for contraception for up to 6 years.
Liletta contains 52 mg of levonorgestrel which is initially released at a rate of approximately 20 µg/day. This rate gradually decreases to around 6.5 mcg/day after 8 years. By the end of the 8th year of life, Liletta should be removed and replaced with a new system at the time of removal if continued use is desired.
The approval was based on additional efficacy data from the phase 3, multi-center, randomized, open-label study ACCESS IUS (ClinicalTrials.gov identifier: NCT00995150), in which Liletta was studied in women aged 16 to 45. The primary endpoint was pregnancy rate calculated as the Pearl Index (PI). For years 7 and 8, patients older than 39 years at the beginning of each year were excluded from the efficacy analysis.
The 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 pregnancy outcomes. 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 2-year cumulative pregnancy rate for years 7 and 8 was 1.37 (95% CI, 0.71-2.62). Of 244 patients who wished to become pregnant after stopping the study, 63.1% became pregnant within 6 months of Liletta removal and 83.2% within 12 months of Liletta removal.
“Now more than ever, patients need access to safe, long-acting, and reversible birth control options,” said study investigator Dr. Courtney Schreiber, Professor and Chief of the Family Planning Division, Department of Obstetrics and Gynecology, Penn Medicine. “Liletta is the only hormonal IUD approved for 8 years with a single continuous study over its entire duration, providing data for patients and clinicians on outcomes (high efficacy, low rate of adverse events) with long-term continuous use.”
- FDA approves Liletta from Medicines360® (Levonorgestrel-releasing intrauterine system) 52 mg for the prevention of pregnancy for up to eight years. press release. Medication360. Retrieved 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 over 8 years of use. Published online May 12, 2022. American Journal of Obstetrics and Gynecology. doi.org/10.1016/j.ajog.2022.05.022.
- Letta. leaflet. drugs 360; 2022. Retrieved November 14, 2022. https://www.rxabbvie.com/pdf/liletta_pi.pdf