SAN FRANCISCO and DUBLIN, Oct. 28,
2019 /PRNewswire/ -- Medicines360, a global nonprofit
organization with a mission to expand women's access to quality
medicines, and Allergan plc (NYSE: AGN), a leading global
pharmaceutical company, 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 six years. With the
FDA approval, LILETTA has the longest approved duration of use for
a hormonal intrauterine device (IUD or IUS) in the U.S., and is
available at the lowest Wholesale Acquisition Cost (WAC) of any IUD
in the U.S.
"Our mission has always been to meet the diverse and unique
health needs of all women, and this approval of LILETTA for up to
six years means women have even greater flexibility and choice when
it comes to their reproductive health," said Jessica Grossman, M.D., CEO of Medicines360.
"Studying our products in robust clinical trials, like ACCESS IUS,
ensures we can provide quality birth control that works for a broad
range of women in the U.S., something we take pride in for leading
the way."
The FDA approval was based on a review of additional efficacy
and safety data from the largest ongoing Phase 3 clinical trial of
an intrauterine system 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 6 years in a
diverse population of women. The study population in the ACCESS IUS
trial included women of various ages, races, and body mass index
(BMI).
"I hear all the time from women that they want a reliable and
long-term option for birth control that is reversible," said
Carolyn Westhoff, M.D., MSC, chief
of the Division of Family Planning, Sarah Billinghurst Solomon
Professor of Reproductive Health, Department of Obstetrics and
Gynecology, Professor of Population and Family Health and
Epidemiology, Columbia University, and
investigator in the ACCESS IUS study. "This groundbreaking trial
has given healthcare providers the ability to confidently offer
women the option of pregnancy prevention for up to six years."
LILETTA is a hormone-releasing system placed in a woman's uterus
to prevent pregnancy for up to six years. The system should be
replaced after six 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 six 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.
"Our partnership with Medicines360 helps to ensure that women
can obtain an effective, long-term birth control option," said
David Nicholson, Ph.D., Allergan's
Executive Vice President and Chief Research and Development
Officer. "Our goal is to provide a variety of contraceptive options
for women so they and their healthcare providers can choose what is
best for them. We are proud to deliver a product that now provides
women with an even longer duration of pregnancy prevention."
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 6
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 partially go into (become embedded) or go
completely through (perforate) the wall of the uterus. If
perforation occurs, LILETTA may move outside the uterus and can
cause internal scarring, infection, or damage to other organs. You
may need surgery to have LILETTA removed if it is embedded or
perforation occurs. 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.
Available by prescription only.
Please see full Prescribing Information for LILETTA.
About Medicines360
Medicines360, located in San
Francisco, California, is a nonprofit global women's health
pharmaceutical company with a mission to remove cost as a barrier
to health by developing and providing affordable Women's Health
products. 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 global pharmaceutical
leader 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 primarily
focused on four key therapeutic areas including medical aesthetics,
eye care, central nervous system and gastroenterology. As part of
its approach to delivering innovation for better patient care,
Allergan has built one of the broadest pharmaceutical and device
research and development pipelines in the industry.
With colleagues and commercial operations located 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; risks
related to impairments; uncertainty associated with financial
projections, projected cost reductions, projected debt reduction,
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, 2018
and Allergan's Quarterly Report on Form 10-Q for the period ended
June 30, 2019. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements.
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