SAN FRANCISCO and DUBLIN, May 6,
2019 /PRNewswire/ -- Medicines360, a nonprofit women's
health pharmaceutical company with a mission of expanding access to
quality medicines, and Allergan plc (NYSE: AGN), a leading global
pharmaceutical company, presented new six-year data from
Medicines360's ongoing multi-center U.S.-based pivotal clinical
trial investigating its intrauterine system (IUS), LILETTA®
(levonorgestrel-releasing intrauterine system) 52 mg, at the
American College of Obstetricians and Gynecologists (ACOG) 2019
Annual Clinical and Scientific Meeting in Nashville, Tenn.
Investigators shared six-year pregnancy rates (by Pearl Index
and life-table analysis) and safety outcomes from the ongoing
ACCESS IUS (A Comprehensive Contraceptive Efficacy
and Safety Study of an IUS) trial, the largest ongoing Phase 3
clinical trial of an IUS in the United
States. The Pearl Index in the first year was 0.15 among
women who were 16 to 35 years old when they enrolled in the study.
At six years, the cumulative life-table pregnancy rate was 0.87.
LILETTA is currently approved for up to five years for the
prevention of pregnancy. The U.S. Food and Drug Administration
(FDA) is currently reviewing an application requesting approval of
LILETTA for up to six years of use based on data from ACCESS
IUS.
The ACCESS IUS trial evaluates a diverse population of women:
women aged 16 to 45, women who have and have not given birth, as
well as obese and non-obese women. Data from women in the U.S.
ranging in ages from 16 to 45 years were collected throughout the
study. Women aged 36 to 45 received the IUS for safety evaluation
only.
Two perforations following IUS placement were diagnosed within
the first year, and no additional perforations have been reported
in the trial to date. Expulsion occurred in 68 participants
(4.0 percent). Most expulsions (73.5 percent) were diagnosed during
the first year, with two diagnosed in year six. Pelvic infection
was diagnosed in 15 women (0.9 percent), with most occurring (73.3
percent) after six or more months of use. Forty women (2.3 percent)
discontinued due to bleeding complaints. Three quarters of these
discontinuations (75.0 percent) occurred in the first two
years.
"Our mission is to increase access to effective contraception
for all appropriate women. These latest clinical findings from
ACCESS IUS are encouraging as they further reinforce LILETTA's
effectiveness and safety for pregnancy prevention in a broad range
of women," said Jessica Grossman,
M.D., CEO of Medicines360. "These data were included in our recent
U.S. regulatory submission requesting approval of LILETTA for up to
six years of use."
The poster was presented by Carolyn
Westhoff, MD, MSC, Chief, 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, on Saturday, May 4,
2019.
ABOUT LILETTA®
Indication
LILETTA® is a sterile, levonorgestrel-releasing
intrauterine system indicated for prevention of pregnancy for up to
5 years. The system should be replaced after 5 years if continued
use is desired.
IMPORTANT SAFETY INFORMATION
Who is not appropriate for LILETTA
Use of LILETTA is contraindicated in women with: known or
suspected pregnancy and cannot be used for post-coital
contraception; congenital or acquired uterine anomaly, including
fibroids, if they distort the uterine cavity and would be
incompatible with correct IUS placement; known or suspected breast
cancer or other hormone-sensitive cancer, now or in the past; known
or suspected uterine or cervical neoplasia; acute liver disease or
liver tumors; untreated acute cervicitis or vaginitis, including
lower genital tract infections (eg, bacterial vaginosis) until
infection is controlled; infected abortion in the past 3 months;
unexplained uterine bleeding; current IUS; acute pelvic
inflammatory disease (PID) or endometritis or history of PID
(except with later intrauterine pregnancy); conditions increasing
susceptibility to pelvic infection; or hypersensitivity to any
component of LILETTA.
Clinical considerations for use and removal of
LILETTA
Use LILETTA with caution after careful assessment in patients
with coagulopathy or taking anticoagulants; migraine, focal
migraine with asymmetrical visual loss or other symptoms indicating
transient cerebral ischemia; exceptionally severe or frequent
headache; marked increase of blood pressure; or severe arterial
disease such as stroke or myocardial infarction. Consider removing
LILETTA if the following arise during use: uterine or cervical
malignancy or jaundice. Because irregular bleeding/spotting is
common during the first months of LILETTA use, exclude endometrial
pathology (polyps or cancer) prior to the insertion of LILETTA in
women with persistent or uncharacteristic bleeding. If the threads
are not visible or are significantly shortened, they may have
broken or retracted into the cervical canal or uterus. If LILETTA
is displaced (eg, expelled or perforated the uterus), remove
it.
Pregnancy-related risks with LILETTA
If pregnancy should occur with LILETTA in place, remove the
intrauterine system because leaving it in place may increase the
risk of spontaneous abortion and preterm labor. Removal or
manipulation may result in pregnancy loss. Evaluate women for
ectopic pregnancy because the likelihood of a pregnancy being
ectopic is increased with LILETTA. Tell women about the signs of
ectopic pregnancy and associated risks, including loss of
fertility. Women with a history of ectopic pregnancy, tubal
surgery, or pelvic infection carry a higher risk of ectopic
pregnancy.
Educate her about PID or endometritis
Insertion of LILETTA is contraindicated in the presence of known
or suspected PID or endometritis or a history of PID unless there
has been a subsequent intrauterine pregnancy. IUSs have been
associated with an increased risk of PID, most likely due to
organisms being introduced into the uterus during insertion. One
woman diagnosed with PID developed the infection within a week of
LILETTA insertion, while the remainder were diagnosed more than six
months after insertion. Counsel women who receive LILETTA to notify
a healthcare provider if they have complaints of lower abdominal or
pelvic pain, odorous discharge, unexplained bleeding, fever, or
genital lesions or sores. PID and endometritis are often associated
with sexually transmitted infections (STIs); LILETTA does not
protect against STIs, including HIV. PID or endometritis may be
asymptomatic but still result in tubal damage and its sequelae.
Inform women about the possibility of PID or endometritis and that
these infections can cause tubal damage leading to ectopic
pregnancy or infertility, or infrequently can necessitate
hysterectomy, or cause death.
Expect changes in bleeding patterns with LILETTA
Spotting and irregular or heavy bleeding may occur during the
first 3 to 6 months. Periods may become shorter and/or lighter
thereafter. Cycles may remain irregular, become infrequent, or even
cease. Consider pregnancy if menstruation does not occur within 6
weeks of the onset of previous menstruation. If a significant
change in bleeding develops during prolonged use, take appropriate
diagnostic measures to rule out endometrial pathology.
Be aware of other serious complications and most common
adverse reactions
Some serious complications with IUSs like LILETTA are sepsis,
perforation, and expulsion. Severe infection or sepsis, including
Group A streptococcal sepsis (GAS), have been reported following
insertion of other LNG-releasing IUSs. Aseptic technique during
insertion of LILETTA is essential to minimize serious infections
such as GAS.
Perforation (total or partial, including penetration/embedment
of LILETTA in the uterine wall or cervix) may occur, most often
during insertion, although the perforation may not be detected
until sometime later. Perforation may also occur at any time during
use. Perforation may reduce contraceptive efficacy. If perforation
is suspected, locate and remove LILETTA as soon as possible.
Surgery may be required. Delayed detection or removal of LILETTA in
case of perforation may result in migration outside the uterine
cavity, adhesions, peritonitis, intestinal perforations, intestinal
obstruction, abscesses, and erosion of adjacent viscera. The risk
of perforation is higher if inserted in lactating women and may be
higher if inserted in women who are postpartum or when the uterus
is fixed retroverted.
Partial or complete expulsion of LILETTA may occur, resulting in
the loss of contraceptive protection.
Delay LILETTA insertion a minimum of 4 weeks or until uterine
involution is complete following a delivery or a second trimester
abortion. Remove a partially expelled LILETTA. If expulsion has
occurred, a new LILETTA may be inserted within 7 days after the
onset of a menstrual period after pregnancy has been ruled out.
Ovarian cysts may occur and are generally asymptomatic, but may
be accompanied by pelvic pain or dyspareunia. Evaluate persistent
ovarian cysts.
In the LILETTA clinical trial, the most common adverse reactions
(≥5% users) were vaginal bacterial infections (18.6%), vulvovaginal
mycotic infections (18.6%), acne (14.9%), nausea or vomiting
(9.8%), dyspareunia (9.1%), headache (8.9%), breast tenderness or
pain (8.3%), pelvic discomfort or pain (8.3%), anxiety (8.1%),
abdominal discomfort or pain (7.8%), depression (6.9%),
dysmenorrhea (6.1%), mood changes (5.8%), increased weight (5.7%),
back pain (5.5%), and vaginal discharge (5.4%).
Teach patients to recognize and immediately report signs or
symptoms of the aforementioned conditions. Evaluate patients 4 to 6
weeks after insertion of LILETTA and then yearly or more often if
clinically indicated.
Please see full Prescribing Information.
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 health care 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
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 primarily focused on four key therapeutic areas including
medical aesthetics, eye care, central nervous system and
gastroenterology.
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; 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.
Except as expressly required by law, Allergan disclaims any intent
or obligation to update these forward-looking statements.
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