Allergan and Medicines360 Get Extension on Duration of Use for Liletta IUD

Allergan’s Liletta intrauterine device (IUD) has now been approved by the FDA to prevent pregnancy for up to five years. The IUD device was originally developed by the non-profit pharmaceutical company Medicines360 and was first granted approval in the US in 2015.

“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 US,” said Dr. Jessica Grossman, CEO of Medicines360. “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.”

Based on Medicines360’s supplemental New Drug Application (sNDA) – filed in February of this year – the regulator has approved the continuous use of the 52 mg levonorgestrel-releasing intrauterine system for up to five years. The application included data from the company’s ACCESS IUS study, the largest ongoing Phase III clinical trial of an IUD in the country.

The trial – the results of which were presented at the American College of Obstetricians and Gynecologists (ACOG) 2018 annual clinical and scientific meeting – involved over 1,750 women and showed that Liletta was over 99 percent effective at preventing pregnancy over a five-year period. The IUD was previously approved for four years of continuous use, but with the label extension, patients will now have an additional 12 months of protection from unplanned pregnancy before having to make the decision of whether to replace the device.

“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,” said Dr. Thomas Kimble, associate dean, assistant professor of obstetrics and gynecology, Eastern Virginia Medical School and principal investigator in the pivotal ACCESS IUS study. “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.”

As part of its mission of expanding women’s access to medicines, Medicines360 offers the Liletta IUD at a discount to clinical covered under the US 340B Drug Pricing Program.

“In our view, this is a landmark approval because it gives women, regardless of income, insurance status or geography, access to an effective and long-term form of hormonal contraception,” said Dr. David Nicholson, Allergan’s chief research and development officer. “We are pleased to strengthen our portfolio of contraceptive options and to continue delivering on our mission of helping women access a method that may be suited for them.”