FDA approves Liletta 52 mg to prevent pregnancy for up to eight years.- Medicines 360.
Medicines360, a global nonprofit organization with a mission to expand women’s access to quality medicines, announced that the FDA has approved Medicines360’s Supplemental New Drug Application (sNDA) to extend the duration of use of Liletta (levonorgestrel-releasing intrauterine system) 52 mg to prevent pregnancy for up to eight years.
This approval is based on data from ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS) that Medicines360 first published in the American Journal of Obstetrics and Gynecology in May 2022. With this FDA approval, Liletta has one of the longest approved durations of use for a hormonal intrauterine device (IUD or IUS) in the U.S.
FDA approval was based on a review of additional efficacy and safety data from the largest Phase III clinical trial of an intrauterine system in the U.S., ACCESS IUS, with 1,751 U.S. women receiving Liletta. Liletta was approximately 99% effective in preventing pregnancy for up to eight years in a diverse population of women. The study population in the ACCESS IUS trial included women of various ages, races, and body mass index (BMI).
“Now more than ever, patients need access to safe, long-acting, and reversible contraceptive options,” said 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. This approval gives healthcare providers the ability to continue offering women a safe and effective option of pregnancy prevention for a long period of time.”
Liletta is a hormone-releasing system placed in the uterus to prevent pregnancy for up to eight years. The system should be replaced after eight years if continued use is desired. Medicines360 received initial approval of Liletta in February 2015.
See- "Levonorgestrel 52 mg intrauterine system efficacy and safety through 8 years of use"-Mitchell D. Creinin, MD, Courtney A. Schreiber, MD, MPH, David K. Turok, MD, MPH, Carrie Cwiak, MD, MPH, Beatrice A. Chen, MD, MPH, Andrea I. Olariu, MD, PhD. Open AccessPublished:May 12, 2022DOI:https://doi.org/10.1016/j.ajog.2022.05.022.
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