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FDA Approves LILETTA – Levonorgestrel Releasing Intrauterine System

Dr. Enrique Jacome
Actavis plc, a leading global specialty pharmaceutical company, and Medicines360, a nonprofit women’s health pharmaceutical company, have announced the approval of LILETTA (levonorgestrel-releasing intrauterine system) by the U.S. Food and Drug Administration (FDA) for use by women to prevent pregnancy for up to three years. LILETTA is placed in the uterus by a healthcare professional and works by continuously releasing levonorgestrel, a progestin, to prevent pregnancy.
Actavis and Medicines360’s groundbreaking partnership will allow women, regardless of income and insurance coverage, to access this new and effective contraceptive option. Through the collaboration, LILETTA will be available in the U.S. commercially as well as at a lower cost to public health clinics enrolled in the 340B Drug Pricing Program.
“At Actavis, we are committed to developing alternative forms of contraceptive options. With the FDA’s approval of LILETTA, we are pleased to offer women a novel IUD which provides three years of safe and effective contraception,” said David Nicholson, PhD., Executive Vice President, Actavis Global Brands R&D.
“The FDA’s approval of LILETTA marks an important milestone for women, providers, and the reproductive health community. LILETTA was designed from the beginning to be accessible by women, regardless of socioeconomic status,” said Pamela Weir, Chief Operating Officer, Medicines360. “In the past, many barriers including expensive upfront costs or lack of insurance coverage have prevented women from obtaining IUDs.” 
The approval of LILETTA was based on the largest hormonal IUD trial, ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS), conducted in the U.S. with 1,751 enrolled women receiving LILETTA. LILETTA was safe and effective for a broad range of women, with a cumulative three year efficacy rate of 99.45 percent. LILETTA is indicated for women regardless of parity or BMI.
LILETTA is a small, flexible plastic T-shaped system which is 32 mm x 32 mm in size. It works to prevent pregnancy by slowly releasing levonorgestrel (LNG), a progestin, at an initial release rate of 18.6 mcg/day with an average in vivo release rate of LNG of approximately 15.6 mcg/day over a period of three years. Generally, LILETTA can be inserted at any time if the provider is reasonably certain that the woman is not pregnant. While LILETTA is intended for use up to three years, it can be removed by a healthcare professional at any time. LILETTA can be replaced at the time of removal with a new LILETTA, if continued contraceptive protection is desired.
“This new hormonal IUD was proven more than 99 percent effective in the largest ever IUD trial conducted in the U.S. It offers a long-term, highly-effective yet reversible option to prevent pregnancy for many women regardless of whether or not they’ve had a child before,” said David L. Eisenberg, M.D., assistant professor of obstetrics and gynecology at Washington University in St. Louis and principal investigator and lead author of the ACCESS IUS study. “This long-acting reversible contraceptive is a desirable option for women looking to prevent pregnancy.”
Actavis and Medicines360 expect that LILETTA will be available for use in the U.S. by Q2 2015.
About the Clinical Trial for LILETTA
The approval of LILETTA is supported by the largest hormonal IUD trial (ACCESS IUS) conducted in the U.S. designed to reflect the U.S. population. This multicenter open-label clinical trial included 1,751 women who received LILETTA. LILETTA was found to be 99.45 percent effective in preventing pregnancy in women regardless of age, parity (previous births), or BMI. The trial is ongoing to evaluate the use of LILETTA for up to four, five and seven years.
LILETTA was studied in women aged 16-45, with a BMI range of 15.8kg/m2 – 61.6kg/m2 (26.9 kg/m2 mean BMI) across women of various races and ethnicities. Most women were Caucasian (78.4 percent) or Black/African American (13.3 percent); 14.7 percent of women were of Hispanic ethnicity. Nearly 58 percent of trial participants were nulliparous (had not previously given birth), the largest percentage of nulliparous IUD patients ever studied. 
In an analysis of women who discontinued the study early, 97 percent returned to menses within three months after LILETTA was removed. Furthermore, in a group of women trying to conceive, 87 percent became pregnant within one year of removal. Additionally, some women were able to conceive as soon as two weeks after removal (12 days). Approximately 19 percent of women treated with LILETTA experienced amenorrhea (absence of menstruation) within one year of treatment and more than one-third experienced amenorrhea by the third year of treatment.
The incidence of ectopic pregnancy in the clinical trial with LILETTA, which excluded women with a history of ectopic pregnancy who did not have a subsequent intrauterine pregnancy, was approximately 0.12 percent per 100 woman-years.
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