Allergan (NYSE:AGN) and the nonprofit women’s health pharma company Medicines360 said today that the FDA approved an application to extend the duration of use for Liletta for the prevention of pregnancy for up to five years.
Medicines360 first won approval for the levonorgestrel-releasing intrauterine device in February of 2015. The system’s latest FDA approval is based on a review of additional efficacy and safety data from an ongoing Phase III trial. The Access IUS trial, which includes 1,751 women across the U.S., found that Liletta is more than 99% effective in preventing pregnancy for up to five years in a range of women.
Registration is open for DeviceTalks Boston! Join us on June 5-6, 2019, as we explore the trends and technology that are shaping the future of the medical device industry.