Allergan plc a leading global pharmaceutical company, and Medicines360, a nonprofit global women's health pharmaceutical company announced the launch of the new LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg IUD single-handed inserter (intrauterine device), for use by women to prevent pregnancy for up to three years. The launch and availability of the single-handed inserter follows the U.S. Food and Drug Administration (FDA) approval received in January 2016.
"As a leader in women's healthcare, Allergan is committed to providing our customers with the most efficient technology and support needed to educate their patients about their reproductive health," said David Nicholson, PhD, Chief R&D Officer at Allergan. "The launch of the LILETTA single-handed inserter continues to demonstrate our commitment to innovation in women's health and serves as another bold example of providing options to better serve our customers and patients."
"We are excited to bring to market the new LILETTA inserter and anticipate that the single-handed process may lead to broader use by healthcare providers, thereby increasing the number of women who have access to this effective contraceptive," said Jessica Grossman, MD, CEO of Medicines360. "Specifically, the new LILETTA inserter includes an ergonomic design allowing for single-handed insertion that can be used with either hand; a bendable tube to accommodate the anatomy of the patient during insertion; and the ability to reload the device if needed before insertion."
A comprehensive product demonstration program is being implemented by Allergan and Medicines360 to help inform clinicians in the private and public sectors about the new inserter.
The approval of the new single-handed inserter was based on the largest hormonal IUD trial, ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS), conducted in the U.S. with 1,751 enrolled women receiving LILETTA, the same trial that supported the initial approval of LILETTA. LILETTA was shown to be safe and effective for a broad range of women, with a cumulative three-year efficacy rate of 99.45 percent. LILETTA is indicated for women regardless of parity or Body Mass Index (BMI) and can be inserted on the same day she visits the clinic, providing that she is not pregnant. During the ACCESS IUS clinical trial, the success rate for insertions with the new single-handed inserter was 99.2%.
LILETTA is a hormone-releasing system placed in a woman's uterus to prevent pregnancy for up to three years and is greater than 99% effective. LILETTA is not permanent, it can be removed at any time by a healthcare provider, offering the flexibility of use for either long- or short-term contraception. LILETTA can be used in women regardless of whether or not they've birthed a child. Allergan initially launched LILETTA in partnership with Medicines360, a non-profit global pharmaceutical company whose mission is to provide access to medicines for women regardless of their socioeconomic status, insurance status, or geographic location. The new LILETTA single-handed inserter with an optimized package received approval in May 2016, and will succeed the two-handed inserter, which was approved by the U.S. FDA in February, 2015.
LILETTA systems with the single-handed inserter will be available in the U.S. commercially as well as at a lower cost to public health clinics enrolled in the 340B Drug Pricing Program.
ABOUT ALLERGAN WOMEN'S HEALTHCARE
Allergan is a leader in women's health care 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.
Allergan plc , headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company's R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 65+ mid-to-late stage pipeline programs in development.
Our Company's success is powered by our more than 15,000 global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.ith commercial operations 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.For more information, visit Allergan's website at www.Allergan.com
Medicines360, located in San Francisco, California, is a nonprofit global women's health pharmaceutical company with a mission to expand access to quality medicines for all women regardless of their socioeconomic status, insurance coverage or geographic location. 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