FDA Approves LILETTA as First Six-Year IUD

The US Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for levonorgestrel-releasing intrauterine system (LILETTA) 52 mg as a hormonal intrauterine device (IUD) capable of preventing pregnancy up to 6 years.

The indication, granted to Medicines360, makes the IUD the longest-duration device of its kind in the US market.

The LILETTA IUD is a hormone-releasing system which first received initial FDA approval in February 2015. It has since been re-developed to include a single-handed inserter capability, and now an extended duration of use. The sNDA approval was based on a review of additional efficacy and safety data taken from an ongoing phase 3 trial involving the IUD in patients in the US.

The 1751-patient ACCESS IUS trial—the largest of its kind—has shown a 99% efficacy with LILETTA in preventing pregnancy for up to 6 years in a diverse population of women. The trial’s population includes women of varying age, race, ethnicity, and body mass index (BMI) to ensure the IUD’s comprehensive benefit.

Jessica Grossman, MD, chief executive officer of Medicines360, said the company’s mission is to address “diverse and unique health needs” of women, and to provide a greater range of reproductive health options.

“Studying our products in robust clinical trials, like ACCESS IUS, ensures we can provide quality birth control that works for a broad range of women in the US, something we take pride in for leading the way,” Grossman said in a statement.

ACCESS IUS study author Carolyn Westhoff, MD, MSc, of Columbia University, backed the proven evidence of the large-scale, long-term trial.

“I hear all the time from women that they want a reliable and long-term option for birth control that is reversible,” Westhoff said. "This groundbreaking trial has given healthcare providers the ability to confidently offer women the option of pregnancy prevention for up to six years."