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.
Tina Raine-Bennett, M.D., CEO of Medicines360, said of the occasion "We are proud to study our products in robust clinical trials, like ACCESS IUS, so we can provide quality birth control that works for a broad range of women. The extended duration of use for LILETTA continues to provide that women can access a reliable, long-term birth control option that offers greater flexibility and expands choice in their reproductive health decisions."
FDA approval was based on a review of additional efficacy and safety data from the largest Phase 3 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. Since then, Medicines360 has continued to invest in the product, which has led to continued optimization of the single-handed inserter and now, the extended duration of use for up to eight years.
LILETTA is commercially available in the U.S., and through Medicines360's nonprofit pharmaceutical model, LILETTA is available at a lower cost to public health clinics enrolled in the 340B Drug Pricing Program.
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