The Food and Drug Administration (FDA) has approved Medicine360’s supplemental new drug application to extend the use of its levongestrel-releasing intrauterine system 52mg (LILETTA) to prevent pregnancy for up to 8 years.
The approval is based on data from A Comprehensive Contraceptive Efficacy & Safety Study of an IUS (ACCESS IUS), originally published in the American Journal of Obstetrics and Gynecology in May 2022. This FDA approval gave this levongestrel-releasing intrauterine system one of the longest approved durations of use for a hormonal IUD in the US.1
“As a nonprofit, mission-driven pharmaceutical organization, we are committed to closing critical gaps in women’s healthcare and ensuring that women have access to the medicines and devices they need to live their best and fullest lives,” said Tina Raine-Bennett, MD, Medicines360’s chief executive officer. “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.”
The clinical trial of ACCESS IUS included data from 1751 women, that ultimately showed this levongestrel-releasing intrauterine system to be 99% effective in preventing pregnancy for up to 8 years in a diverse population of races. The study population included women of various ages, races, and body mass index categories.
“Now more than ever, patients need access to safe, long-acting, and reversible contraceptive options,” said Courtney Schreiber, MD, MPH, 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.”
1. FDA Approves Medicines360’s LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Eight Years – Medicines360. Medicines360.org. Published November 14, 2022. Accessed November 15, 2022. https://www.medicines360.org/2022/11/14/fda-approves-medicines360s-liletta-levonorgestrel-releasing-intrauterine-system-52-mg-to-prevent-pregnancy-for-up-to-eight-years/