FDA accepts for filing sNDA for Liletta 52 mg

Application seeks to extend duration of use up to 4 years for Liletta.

Allergan and Medicines360, a nonprofit global women's health pharmaceutical company, have announced that the FDA has accepted for filing the company's supplemental New Drug Application (sNDA) to potentially extend the duration of use for the prevention of pregnancy from up to 3 years to up to 4 years for Liletta (levonorgestrel-releasing intrauterine system) 52 mg.

The supplement currently being reviewed by FDA includes additional efficacy and safety data from an ongoing US-based Phase III hormonal IUD trial, ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS), with 1,751 women receiving Liletta. Liletta was shown to be safe and effective for a broad range of women regardless of age, race, parity or Body Mass Index (BMI).

Liletta was first approved in February 2015 with a two-handed inserter and received additional FDA approval in January 2016 for a new single-handed inserter. Liletta systems with the single-handed inserter are commercially available in the US as well as at a lower cost to public health clinics enrolled in the 340B Drug Pricing Program.

Liletta is a hormone-releasing system placed in a woman's uterus to prevent pregnancy for up to 3 years and is greater than 99% effective. Liletta is not permanent; it can be removed at any time by a healthcare provider, offering the flexibility of use for either long- or short-term contraception. LILETTA can be used in women regardless of whether or not they've birthed a child.