DUBLIN and SAN FRANCISCO,
Oct. 16, 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, 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 five years.
"A large and diverse population of women already use LILETTA as
a safe, long-acting and reversible contraceptive option. This
approval means that LILETTA is now indicated for up to 5 years of
use. To date, no hormonal IUD has been studied across more women in
a single Phase 3 clinical trial conducted in the U.S.," said
Jessica Grossman, M.D., CEO of
Medicines360. "In partnership with Allergan, we remain steadfast in
our mission to help women access available birth control methods
that are appropriate for them, regardless of their income."
The FDA approval was based on a review of additional efficacy
and safety data from the largest ongoing intrauterine system (IUS),
otherwise known as intrauterine device (IUD), Phase 3 clinical
trial 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 5 years in a broad
range of women. LILETTA is effective regardless of age, race, body
mass index (BMI) or parity (whether or not the woman had given
birth to at least one child).
"I hear from women every day that they want contraceptive
options that are proven and provide them with flexibility in
preventing pregnancy. Unfortunately, this isn't always a reality,"
said Thomas Kimble, M.D., associate
dean, assistant professor of obstetrics and gynecology,
Eastern Virginia Medical School and
principal investigator in the pivotal ACCESS IUS study. "I can
confidently recommend LILETTA as a rigorously tested choice for
patients who want long-term reversible birth control. The fact that
it is now indicated for up to five years, instead of four, offers
my patients the flexibility of use for either long- or short-term
contraception."
LILETTA is a hormone-releasing system placed in a woman's uterus
to prevent pregnancy for up to five years. The system should be
replaced after five 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 5 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.
"In our view, this is a landmark approval because it gives
women, regardless of income, insurance status or geography, access
to an effective and long-term form of hormonal contraception," said
David Nicholson, Ph.D., Allergan's
chief research and development officer. "We are pleased to
strengthen our portfolio of contraceptive options and to continue
delivering on our mission of helping women access a method that may
be suited for them."
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 5 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 (PID occurs in less than 1%
of users)
- Have an untreated lower genital infection now
- Have had an infection from an abortion within the last 3
months
- Can get infections easily; for example, if you:
-
- Have problems with your immune system
- Have multiple sexual partners or your partner has multiple
sexual partners
- 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 labor or 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 are usually
sexually transmitted. You have a higher chance of getting PID or
endometritis if you or your partner has sex with other partners.
PID or endometritis 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.
Tell your healthcare provider right away if you have any of these
signs of PID or endometritis: long-lasting or heavy bleeding,
unusual vaginal discharge, low abdominal pain, painful sex, chills,
or fever
- 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). Expulsion
occurs in about 4 out of 100 women, most often in the first year of
use. You may become pregnant if LILETTA comes out. If you think
that LILETTA has come out, use another birth control method like
condoms and spermicide or do not have sex (vaginal intercourse)
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
leader. 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; risks associated with
divestitures, acquisitions, mergers and joint ventures; uncertainty
associated with financial projections, debt reduction, 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,
2017 and Allergan's Quarterly Report on Form 10-Q for the
period ended June 30, 2018. Except as
expressly required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements.
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SOURCE Medicines360