Medicines360

Healthcare for each woman. Access for all women.

FDA Approves Medicines360’s sNDA for LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Four Years

Published 6 August 2017

Allergan plc (NYSE:AGN), a leading global pharmaceutical company, and Medicines360, a global nonprofit women's health pharmaceutical company with a mission of expanding access to quality medicines, 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 four years.

“The newly approved indication for LILETTA is an important milestone in our work to make this IUD available to women, in partnership with Allergan,” said Jessica Grossman, M.D., CEO of Medicines360. “Our mission is to help women access safe and effective contraception, and the new four-year indication for LILETTA is good news for women who want the reliability and flexibility that a hormonal IUD can offer.”

The FDA approval was based on a review of additional efficacy and safety data from an ongoing U.S.-based Phase 3 hormonal IUD trial, ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS [intrauterine system]), with 1,751 U.S. women receiving LILETTA. LILETTA was shown to be greater than 99 percent effective in preventing pregnancy in a broad range of women, regardless of age, race, body mass index (BMI) or parity (whether or not the woman had given birth to at least one child).

“Allergan is committed to advancing options in women's healthcare, and we are pleased to partner with Medicines360 to further our common goal to offer women effective and safe contraceptives,” said David Nicholson, Ph.D., Chief Research and Development Officer, Allergan. “The FDA’s approval of an extended indication for LILETTA is another step forward for women’s reproductive health options.”

LILETTA is a hormone-releasing system placed in a woman’s uterus to prevent pregnancy for up to four years. Allergan and Medicines360 partnered to launch LILETTA, which first was approved in February 2015, and received an additional FDA approval in January 2016 for the single-handed inserter.

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.

“IUDs are among the safest and most effective forms of contraception and are a critical tool in reducing unintended pregnancy. As a clinician, I appreciate that the clinical trial demonstrated LILETTA’s safety and efficacy across a wide range of women, regardless of age, BMI and ethnicity,” said Dr. David Turok, Associate Professor, University of Utah Department of Obstetrics and Gynecology.

ABOUT LILETTA®

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 4 years.

Important Risk Information About LILETTA

Do not use LILETTA if you:

Are or might be pregnant; LILETTA cannot be used as an emergency contraceptive

Have a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis unless you have had a normal pregnancy after the infection went away

Have an untreated lower genital infection now

Have had an infection from an abortion within the last 3 months

Can get infections easily (e.g., if you have problems with your immune system, if you or your partner have multiple sexual partners, if you use or abuse intravenous drugs)

Have or suspect you might have cancer of the uterus or cervix

Have bleeding from the vagina that has not been explained

Have short-term (acute) liver disease or liver tumor

Have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past

Have an intrauterine system (IUS) in your uterus already

Have a condition of the uterus that changes the shape of the uterine cavity, such as large fibroid tumors

Are allergic to levonorgestrel, silicone, polyethylene, or barium sulfate

Call your healthcare provider right away if you think you are pregnant. If you get pregnant while using LILETTA, you may have an ectopic pregnancy, which means the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain especially with missed periods may be a sign of ectopic pregnancy. Ectopic pregnancy can cause internal bleeding. There are also risks if you get pregnant while using LILETTA and the pregnancy is in the uterus. Severe infection and premature delivery can occur with pregnancies that continue with an IUS

Although uncommon, pregnancy while using LILETTA can be life threatening and may result in loss of pregnancy or fertility

Bleeding and spotting may increase in the first 3 to 6 months and remain irregular. Periods over time usually become shorter, lighter or may stop

Life-threatening infection can occur within the first few days after LILETTA is placed. Call your healthcare provider immediately if you develop severe pain or fever shortly after LILETTA is placed

Some IUS users get a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis. These can cause serious problems such as infertility, ectopic pregnancy or pelvic pain that does not go away. More serious cases of PID or endometritis may require surgery. Removal of the uterus (hysterectomy) is sometimes needed. In rare cases, infections that start as PID or endometritis can even cause death.

LILETTA may become attached to (embedded) or go through the uterus (perforation). If perforation occurs, LILETTA may move outside the uterus and can cause internal scarring, infection, or damage to other organs and you may need surgery to have LILETTA removed. Risk of perforation is increased in breastfeeding women.

LILETTA may come out of your uterus (expulsion). You may become pregnant if LILETTA comes out. If you think that LILETTA has come out, use another birth control method (e.g., condoms and spermicide) or do not have sex until you are seen by a healthcare provider

Ovarian cysts may occur but usually disappear

LILETTA does not protect against HIV or STDs.

For full prescribing information, visit www.LILETTA.com

About Medicines360

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.

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 bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is 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 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, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs currently in development.

Allergan’s success is powered by our more than 18,000 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.

With 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 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; 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, 2016 and Allergan's Quarterly Report on Form 10-Q for the period ended March 31, 2017. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.