FDA to Review Liletta Use for Up to 4 Years
Allergan and Medicines360 announced that the Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) for Liletta (levonorgestrel-releasing intrauterine system).
The sNDA proposed extending the duration of use for the prevention of pregnancy from up to 3 years to up to 4 years for Liletta. The application contains additional efficacy and safety data from the ongoing Phase 3 hormonal intrauterine device (IUD) trial called ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS). The study, which included 1,751 women receiving Liletta, found that it was safe and effective for women regardless of age, race, parity or body mass index (BMI).
Liletta, a progestin IUD, was initially approved in February 2015 with a 2-handed inserter and then later approved in January 2016 for a single-handed inserter. Liletta is not permanent and can be removed by a clinician at any time. Studies of levonorgestrel-releasing IUSs suggest several mechanisms for pregnancy prevention: prevention of fertilization due to thickening of the cervical mucus, which inhibits sperm passage through the cervix, and inhibition of sperm mobility and function (capacitation) and alteration of the endometrium.
Liletta contains levonorgestrel 52mg and is packaged in a carton of one sterile unit.
For more information call (855) 706-4508 or visit Liletta.com.