FDA extends the use of Lilleta

FDA has expanded the duration of use of Allergan’s Lilleta to prevent pregnancy for up to six years, after Supplemental New Drug Application (sNDA) by Medicines360, a global nonprofit organization with a mission to expand women’s access to quality medicines, thus making levonorgestrel-releasing intrauterine system, 52 mg to, the longest approved duration of use of any hormonal IUDs.

LILETTA proved to be more than 99 percent effective in preventing pregnancy for up to 6 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), said Medicines360 in a press release.

“Our mission has always been to meet the diverse and unique health needs of all women, and this approval of Lilleta for up to six years means women have even greater flexibility and choice when it comes to their reproductive health,” said Jessica Grossman, M.D., CEO of Medicines360. “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 U.S., something we take pride in for leading the way.”

David Nicholson, Allergan’s Executive Vice President and Chief Research and Development Officer, said: “Our partnership with Medicines360 helps to ensure that women can obtain an effective, long-term birth control option. Our goal is to provide a variety of contraceptive options for women so they and their healthcare providers can choose what is best for them. We are proud to deliver a product that now provides women with an even longer duration of pregnancy prevention.”

LILETTA is a hormone-releasing system placed in a woman’s uterus to prevent pregnancy for up to six years. The system should be replaced after six years if continued use is desired. Medicines360 received initial approval of LILETTA in February 2015. Since then, Medicines360 and Allergan have continued to invest in the product, which has led to the introduction of the single-handed inserter and, now, the extended duration of use for up to six years.

LILETTA is commercially available in the U.S., and through Medicines360’s unique mission-driven model, LILETTA is available at a lower cost to public health clinics enrolled in the 340B Drug Pricing Program.