Allergan plc, a leading global pharmaceutical company, and Medicines360, a global nonprofit women’s health pharmaceutical company with a mission of expanding access to quality medicines, today announced that the U.S. FDA has accepted for filing Medicines360’s supplemental New Drug Application (sNDA).
The application aims to extend the duration of use for the prevention of pregnancy from up to four years to up to five years for LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg.
The sNDA currently being reviewed by the FDA is based on additional efficacy and safety data from the largest ongoing Phase 3 hormonal IUD trial in the U.S., ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS [intrauterine system]), with 1,751 women receiving LILETTA.
LILETTA is a hormone-releasing system placed in a woman’s uterus to prevent pregnancy for up to four years and is more than 99% effective. Women can use LILETTA whether or not they have previously given birth. LILETTA is a long-term reversible contraceptive (LARC) and can be removed at any time by a healthcare provider, offering the flexibility of use for either long- or short-term contraception.
LILETTA is currently approved for up to 4 years of use and should be replaced after 4 years if continued use is desired. In the ongoing study, LILETTA was shown to be effective for a broad range of women regardless of age, race, parity or Body Mass Index (BMI).
Allergan and Medicines360 partnered to launch LILETTA, which first was approved in February 2015, and received an additional FDA approval in January 2016 for its single-handed inserter. In August of 2017, the duration of use of LILETTA for the prevention of pregnancy was approved for up to four 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.
