The approval extends the use of Liletta for an additional two years. It is the only hormonal IUD approved for continuous use up to eight years.
The FDA has approved Medicines360’s supplemental new drug application (sNDA) to extend the duration of use of Liletta (levonorgestrel-releasing intrauterine system). It is now extended to prevent pregnancy for up to eight years; previously the device could be used for up to six years. With this FDA approval, Liletta one of the longest approved durations of use for a hormonal intrauterine device (IUD) in the United States. The IUD first received approval in 2015.
“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,” Tina Raine-Bennett, M.D., chief executive officer of Medicines360, said in a press release.
This approval is based on data from ACCESS IUS study that Medicines360 first published in the American Journal of Obstetrics and Gynecology in May 2022. The phase 3 clinical trial recruited 1,751 women in the United States. Liletta was about 99% effective in preventing pregnancy for up to eight years in a diverse population of women. No new safety concerns arose with extended use. Among the most common reported events were Vulvovaginal infections with bacteria or yeast and urinary tract infections.
The wholesale acquisition of Liletta is $845.10, according to AbbVie. Medicines360 and AbbVie have partnered for the marketing of Liletta.