Allergan and Medicines360 announced the U.S. Food and Drug Administration (FDA) approved Medicines360's Supplemental New Drug Application (sNDA) to extend the duration of use of Liletta (levonorgestrel-releasing intrauterine system) 52 mg for the prevention of pregnancy for up to five 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. To date, no hormonal IUD has been studied across more women in a single Phase 3 clinical trial conducted in the U.S.," said Jessica Grossman, M.D., CEO of Medicines360. "In partnership with Allergan, we remain steadfast in our mission to help women access available birth control methods that are appropriate for them, regardless of their income."
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The FDA approval was based on a review of additional efficacy and safety data from the largest ongoing intrauterine system (IUS), otherwise known as intrauterine device (IUD), Phase 3 clinical trial in the U.S., ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS), with 1,751 U.S. women receiving Liletta. Liletta proved to be more than 99 percent effective in preventing pregnancy for up to 5 years in a broad range of women. LILETTA is effective regardless of age, race, body mass index (BMI) or parity (whether or not the woman had given birth to at least one child).
"I hear from women every day that they want contraceptive options that are proven and provide them with flexibility in preventing pregnancy. Unfortunately, this isn't always a reality," said Thomas Kimble, M.D., associate dean, assistant professor of obstetrics and gynecology, Eastern Virginia Medical School and principal investigator in the pivotal ACCESS IUS study. "I can confidently recommend Liletta as a rigorously tested choice for patients who want long-term reversible birth control. 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."
Liletta is a hormone-releasing system placed in a woman's uterus to prevent pregnancy for up to five years. The system should be replaced after five 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 5 years.