Research & Development
Allergan plc & Medicines360 partnership wins US FDA approval of sNDA for duration extension of contraceptive LILETTA
17 October 2018 -

Pharmaceutical company Allergan plc (NYSE:AGN) reported on Tuesday the receipt of the US Food and Drug Administration (FDA) approval for Medicines360's Supplemental New Drug Application (sNDA) for the extension of the duration of use of LILETTA (levonorgestrel-releasing intrauterine system) in 52 mg for the prevention of pregnancy for up to five years.

This US FDA approval was based on a review of additional efficacy and safety data from the partnership's largest ongoing intrauterine system (IUS), known as intrauterine device (IUD), Phase 3 clinical trial in the US, ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS), with 1,751 US women receiving LILETTA.

The companies added that LILETTA proved to be more than 99% effective in preventing pregnancy for up to five years in a broad range of women as well as effective regardless of age, race, body mass index (BMI) or parity (whether or not the woman had given birth to at least one child).

According to the companies, 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. it has introduced the single-handed inserter and, now, the extended duration of use for up to five years.

In the US, LILETTA is commercially available via Medicines360's unique mission-driven model as well as at a lower cost under the public health clinics' 340B Drug Pricing Programme.