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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SOURCE Allergan plc