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.
“A large and diverse population of women already use Liletta as a safe, long-acting and reversible contraceptive option. This approval means that Liletta is now indicated for up to 5 years of use. To date, no hormonal IUD has been studied across more women in a single Phase III clinical trial conducted in the U.S.,” Dr. Jessica Grossman, CEO of Medicines360, said in prepared remarks. “In partnership with Allergan, we remain steadfast in our mission to help women access available birth control methods that are appropriate for them, regardless of their income.”
“I hear from women every day that they want contraceptive options that are proven and provide them with flexibility in preventing pregnancy. Unfortunately, this isn’t always a reality,” principal investigator Dr. Thomas Kimble added. “I can confidently recommend Liletta as a rigorously tested choice for patients who want long-term reversible birth control. The fact that it is now indicated for up to five years, instead of four, offers my patients the flexibility of use for either long- or short-term contraception.”