FDA Acceptance of Medicines360's Filing for supplemental New Drug Application for LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg
DUBLIN and SAN FRANCISCO, Feb. 22, 2018 /PRNewswire/ -- 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, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Medicines360's supplemental New Drug Application (sNDA). The application aims to extend the duration of use for the prevention of pregnancy from up to four years to up to five years for LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg.
The sNDA currently being reviewed by the FDA is based on additional efficacy and safety data from the largest ongoing Phase 3 hormonal IUD trial in the U.S., ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS [intrauterine system]), with 1,751 women receiving LILETTA.
LILETTA is a hormone-releasing system placed in a woman's uterus to prevent pregnancy for up to four years and is more than 99% effective. Women can use LILETTA whether or not they have previously given birth. LILETTA is a long-term reversible contraceptive (LARC) and can be removed at any time by a healthcare provider, offering the flexibility of use for either long- or short-term contraception. LILETTA is currently approved for up to 4 years of use and should be replaced after 4 years if continued use is desired. In the ongoing study, LILETTA was shown to be effective for a broad range of women regardless of age, race, parity or Body Mass Index (BMI).
Allergan and Medicines360 partnered to launch LILETTA, which first was approved in February 2015, and received an additional FDA approval in January 2016 for its single-handed inserter. In August of 2017, the duration of use of LILETTA for the prevention of pregnancy was approved for up to four 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.
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 and advocacy groups. 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.
Allergan's success is powered by our 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; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; uncertainty associated with financial projections, projected cost reductions, 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, 2016 and Allergan's Quarterly Report on Form 10-Q for the period ended September 30, 2017. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
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