FDA Approves Liletta IUD for 5 Years of Contraceptive Use

The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application to extend the approved use of the Liletta (levonorgestrel-releasing intrauterine system [IUS]). The Liletta IUS, also known as an intrauterine device (IUD), is now approved for the prevention of pregnancy for up to 5 years.

"A large and diverse population of women already use Liletta as a safe, long-acting and reversible contraceptive option. This approval means that Liletta is now indicated for up to 5 years of use," said Jessica Grossman, MD, CEO of Medicines360.

The FDA’s approval was based on new data from the ongoing ACCESS IUS study of Liletta in women 16 to 45 years of age. The randomized, open-label trial included 1751 women who received Liletta. Of those 58% were nulliparous and 42% were parous. The trial did not limit participation based on body mass index (BMI) and the range among participatns was 15.8 to 61.6 kg/m². The mean BMI was 26.9 kg/m² and 24% were overweight, 24% were obese (BMI ≥ 30 kg/m²), and 5% were morbidly obese (BMI ≥ 40 kg/m²).

Demographics of study participants were: Caucasian 78.4%, Black or African American 13.3%, Asian 3.9%, American Indian or Alaska Native 1.2%, Native Hawaiian or Other Pacific Islander 0.3%; 2.9% identified multiple races, and 14.7% indicated Hispanic ethnicity. Liletta’s effectiveness did not appear to vary by parity, race/ethnicity, or BMI.

The Liletta IUD contains 52 mg of levonorgestrel, a progestin, which is initially released at approximately 20 mcg/day. That rate decreases to about half after 5 years. The average release rate of levonorgestrel is 14.7 mcg/day over a period of 5 years.

The Liletta Prescribing Information specifies that the IUD should not be inserted if a patient is pregnant or suspected to be pregnant and that it does not provide emergency contraception. Additionally, Liletta should not be used if the uterine cavity is distorted and would be incompatible with correct placement, if there is acute pelvic inflammatory disease or endometritis, or if there was an infected abortion in the past 3 months.

If a pregnancy occurs, the Liletta IUD does increase the risk of ectopic pregnancy, pregnancy loss, septic abortion, and premature labor and delivery. Perforation of the uterus can occur with Liletta use as well as partial or complete expulsion from the uterus. Menstrual bleeding patterns may be altered or become irregular.

The most common adverse reactions in trial, occurring in >10% of users, are vaginal bacterial infections, vulvovaginal mycotic infections, and acne.

Liletta was originally approved by the FDA in 2015 for up to 3 years of use as a contraceptive. Earlier analyses of the ACCESS IUS data showed that Liletta had a cumulative 3-year efficacy rate of 99.45%. Additionally, among women who discontinued the study, 97% began to menstruate within 3 months of removal. Among women trying to conceive, 87% became pregnant within 1 year of removal and some were able to conceive as soon as 12 days after removal.

In 2017, Liletta 52 mg was approved for the prevention of pregnancy for up to 4 years.

"I can confidently recommend LILETTA as a rigorously tested choice for patients who want long-term reversible birth control,” said Thomas Kimble, MD, associate dean, assistant professor of obstetrics and gynecology, Eastern Virginia Medical School and principal investigator in the pivotal ACCESS IUS study. “The fact that it is now indicated for up to five years, instead of four, offers my patients the flexibility of use for either long- or short-term contraception."