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FDA Approves Liletta (levonorgestrel-releasing intrauterine system) to Prevent Pregnancy for up to Six Years

SAN FRANCISCO and DUBLIN October 28, 2019 – Medicines360, a global nonprofit organization with a mission to expand women’s access to quality medicines, and Allergan plc (NYSE: AGN), a leading global pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved Medicines360’s Supplemental New Drug Application (sNDA) to extend the duration of use of Liletta (levonorgestrel-releasing intrauterine system) 52 mg for the prevention of pregnancy for up to six years. With the FDA approval, Liletta has the longest approved duration of use for a hormonal intrauterine device (IUD or IUS) in the U.S., and is available at the lowest Wholesale Acquisition Cost (WAC) of any IUD in the U.S.

“Our mission has always been to meet the diverse and unique health needs of all women, and this approval of Liletta for up to six years means women have even greater flexibility and choice when it comes to their reproductive health,” said Jessica Grossman, M.D., CEO of Medicines360. “Studying our products in robust clinical trials, like ACCESS IUS, ensures we can provide quality birth control that works for a broad range of women in the U.S., something we take pride in for leading the way.”

The FDA approval was based on a review of additional efficacy and safety data from the largest ongoing Phase 3 clinical trial of an intrauterine system in the U.S., ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS), with 1,751 U.S. women receiving Liletta. Liletta proved to be more than 99 percent effective in preventing pregnancy for up to 6 years in a diverse population of women. The study population in the ACCESS IUS trial included women of various ages, races, and body mass index (BMI).

“I hear all the time from women that they want a reliable and long-term option for birth control that is reversible,” said Carolyn Westhoff, M.D., MSC, chief of the Division of Family Planning, Sarah Billinghurst Solomon Professor of Reproductive Health, Department of Obstetrics and Gynecology, Professor of Population and Family Health and Epidemiology, Columbia University, and investigator in the ACCESS IUS study. “This groundbreaking trial has given healthcare providers the ability to confidently offer women the option of pregnancy prevention for up to six years.”

Liletta is a hormone-releasing system placed in a woman’s uterus to prevent pregnancy for up to six years. The system should be replaced after six years if continued use is desired. Medicines360 received initial approval of Liletta in February 2015. Since then, Medicines360 and Allergan have continued to invest in the product, which has led to the introduction of the single-handed inserter and, now, the extended duration of use for up to six years.

Liletta is commercially available in the U.S., and through Medicines360’s unique mission-driven model, Liletta is available at a lower cost to public health clinics enrolled in the 340B Drug Pricing Program.

“Our partnership with Medicines360 helps to ensure that women can obtain an effective, long-term birth control option,” said David Nicholson, Ph.D., Allergan’s Executive Vice President and Chief Research and Development Officer. “Our goal is to provide a variety of contraceptive options for women so they and their healthcare providers can choose what is best for them. We are proud to deliver a product that now provides women with an even longer duration of pregnancy prevention.”

Indication

Liletta (levonorgestrel-releasing intrauterine system) 52 mg is a hormone-releasing system placed in your uterus to prevent pregnancy for as long as you want for up to 6 years.

About Medicines360

Medicines360, located in San Francisco, California, is a nonprofit global women’s health pharmaceutical company with a mission to remove cost as a barrier to health by developing and providing affordable Women’s Health products. Medicines360 is committed to working with healthcare providers, advocacy groups and patients to deliver innovative and meaningful treatments that help women around the world have greater access to the medicines they need. For more information, visit www.medicines360.org

About Allergan Women’s Healthcare

Allergan is a leader in women’s healthcare that is dedicated to developing and commercializing best-in-class pharmaceuticals to improve the health and wellness of women. Allergan takes a holistic and a best-in-class approach to women’s healthcare as it prioritizes educational partnerships with OB/GYNs. The mission of Allergan Women’s HealthCare extends beyond its pharmaceutical products to ensure that all women can make informed decisions about their health and have access to high-quality medications. Allergan is committed to investing in programs that support the education and well-being of all women.

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.

With colleagues and commercial operations located in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

For more information, visit Allergan’s website at www.Allergan.com.

Forward-Looking Statement
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan’s current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan’s current expectations depending upon a number of factors affecting Allergan’s business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan’s products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; risks related to impairments; uncertainty associated with financial projections, projected cost reductions, projected debt reduction, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan’s periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan’s Annual Report on Form 10-K for the year ended December 31, 2018 and Allergan’s Quarterly Report on Form 10-Q for the period ended June 30, 2019. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

Source: Medicines360

Posted: October 2019

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