The FINANCIAL — Actavis plc one of the leading global pharmaceutical companies and one of the leaders in women’s health care, and Medicines360, a nonprofit women’s health pharmaceutical company, announced on April 13 that LILETTA (levonorgestrel-releasing intrauterine system) 52 mg is now available in the U.S. for use by women to prevent pregnancy for up to three years.
LILETTA was approved by the U.S. Food and Drug Administration (FDA) on February 26, 2015, based on the largest hormonal IUD trial conducted in the U.S., ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS). LILETTA is placed in the uterus by a healthcare professional and works by continuously releasing levonorgestrel, a progestin, to prevent pregnancy, according to Actavis.
“The availability of LILETTA marks another significant achievement in women’s health,” said Carolyn Westhoff, MD, M.Sc, Professor, Division Director, Family Planning and Preventive Services, Columbia University Medical Center. “It’s critical that women have choices when it comes to their preferred contraception and I am pleased that I can offer my appropriate patients this new safe and effective option.”
With the availability of LILETTA, IUD-appropriate women, regardless of financial status and insurance coverage, can now access this new safe and effective IUD through Actavis and Medicines360’s partnership. LILETTA is now commercially available in doctor’s offices in the U.S. and through this groundbreaking partnership, at a lower price for public health clinics enrolled in the 340B Drug Pricing Program.
“The commercial availability of LILETTA represents a remarkable next step for women’s health in the U.S., providing IUD-appropriate women, regardless of income and insurance coverage, with a safe and effective contraceptive option,” said Pamela Weir, Chief Operating Officer, Medicines360. “Through this truly innovative partnership, women will now have an accessible, affordable option for effective, long-term contraception.”
“Actavis is committed to the continued development and commercialization of safe and effective contraceptives to address unmet needs in women’s health,” said Bill Meury, President, Actavis Branded Pharma. “LILETTA is a progestin-only intrauterine device with >99% efficacy demonstrated over 3 years. Our groundbreaking partnership with Medicines360 will provide increased access to this novel IUD to women across the private and public healthcare systems in the U.S.”