NORTH CHICAGO, Ill.,
April 7, 2017 /PRNewswire/
-- AbbVie (NYSE: ABBV), a global biopharmaceutical company in
cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), today
announced detailed results from a Phase 2b clinical trial
evaluating the efficacy and safety of elagolix alone or in
combination with add-back therapy (estradiol/norethindrone acetate)
compared to placebo. The data demonstrated that elagolix,
with and without add-back therapy, met the primary efficacy
endpoint of reduced heavy menstrual bleeding as compared to placebo
(p<0.001). These results were shared for the first time in an
oral presentation at the third Congress of the Society of
Endometriosis and Uterine Disorders (SEUD) in Singapore.
Uterine fibroids are the most common type of abnormal growth in
a woman's pelvis and can affect about 20-80 percent of women by age
50.1 African American women are more likely to
experience fibroids and do so at a younger age.2
Fibroids can be asymptomatic, but in some women, fibroids can cause
symptoms such as heavy menstrual bleeding, painful periods, vaginal
bleeding at times other than menstruation, and
anemia.1
"A majority of premenopausal women will be diagnosed with
uterine fibroids and it is the leading indication for hysterectomy
in the United States," said
James A. Simon, MD, clinical
professor of obstetrics and gynecology, George
Washington University, and medical director, Women's Health
& Research Consultants® in Washington, D.C. "The results presented today
demonstrate that elagolix was well tolerated and has the potential
to be an important treatment option for women suffering from heavy
menstrual bleeding associated with uterine fibroids."
The study's primary endpoint assessed the change in menstrual
blood loss from baseline to month six utilizing the alkaline
hematin method, a standard measurement for menstrual blood loss.
The effects of elagolix on heavy menstrual bleeding were rapid as
evidenced by a significant reduction in the number of heavy
bleeding days based on assessment at month six compared to
placebo. Women treated with elagolix had significant
increases in hemoglobin concentration from baseline to month six
compared to placebo. Uninterrupted treatment with elagolix was
associated with decreased symptom severity and improved quality of
life as assessed by the Uterine Fibroid Symptom and QoL (UFS-QoL)
questionnaire.
"Current non-surgical treatments indicated for uterine fibroids
are limited, and women suffering from heavy menstrual bleeding
associated with uterine fibroids need more options," said
Rob Scott, M.D., Vice President,
Development and Chief Medical Officer, AbbVie. "The positive
results from this clinical trial represent a significant milestone
in the development of elagolix, support AbbVie's ongoing Phase 3
uterine fibroids research and demonstrate our continued commitment
to address complex and serious diseases."
The Phase 2b uterine fibroids study (M12-813) was a 24-week,
multicenter, double-blind, randomized, placebo-controlled, parallel
group clinical trial that evaluated elagolix in women with heavy
uterine bleeding associated with uterine fibroids. It was conducted
in 567 premenopausal women, age 18 to 51, at 100 sites in
the United States, Canada, Puerto
Rico, Chile and the United
Kingdom. The two cohort design study evaluated the safety and
efficacy of two elagolix treatment regimens (300mg BID and 600mg
QD) alone and in combination with two different strengths of
add-back therapy (estradiol/norethindrone acetate). The data
presented were results from the 300mg cohort. Results from
the 600mg cohort were similar and will be reported in a future
publication.
The most common adverse events reported were hot flush, headache
and insomnia, which occurred more frequently in the elagolix
treatment groups compared to placebo. Add-back therapy reduced the
incidence of hot flushes in a dose-dependent manner. All elagolix
treatment groups had a decrease in mean endometrial thickness from
baseline to month six compared to placebo and there were no adverse
endometrial findings from the endometrial biopsies at baseline or
month six. Reduction in bone mineral density associated with
elagolix alone was attenuated when elagolix was co-administered
with add-back therapy, with marginal effects on efficacy.
The Phase 3 elagolix uterine fibroids program includes two
replicate, pivotal, six-month efficacy and safety studies followed
by a six-month safety and efficacy extension study. The primary
endpoint in Phase 3 studies will assess the reduction in heavy
menstrual bleeding compared to placebo as measured by the alkaline
hematin method.
About Uterine Fibroids
Uterine fibroids (also called
leiomyomas or myomas) are non-cancerous, hormonally-responsive
muscle tissue tumors of the uterus.2 Fibroids are the
most common type of abnormal growth in a woman's pelvis and can
affect about 20-80 percent of women by age 50.1 African
American women are more likely to experience fibroids and to do so
at a younger age.2 Fibroids can range in size, shape,
number and location.1 Fibroids can be asymptomatic, but
in some women, fibroids can cause symptoms such as heavy menstrual
bleeding, painful periods, vaginal bleeding at times other than
menstruation, anemia, pain in the abdomen or lower back, pain
during sex, difficulty urinating or frequent urination,
constipation, rectal pain or difficulty getting
pregnant.1 Treatment options for uterine fibroids
include surgery (hysterectomy, myomectomy), hysteroscopy,
endometrial ablation, uterine artery embolization, magnetic
resonance imaging-guided ultrasound and medical management with
treatments such as oral contraceptives, progestins, selective
progesterone receptor modulators, and GnRH agonists, many of which
are not specifically indicated for the treatment of uterine
fibroids.1
About Elagolix
Elagolix, a gonadotropin-releasing
hormone (GnRH) receptor antagonist, is an orally administered,
short-acting molecule that blocks endogenous GnRH signaling by
binding competitively to GnRH receptors in the pituitary gland.
Administration results in rapid, reversible, dose-dependent
inhibition of luteinizing hormone (LH) and follicle-stimulating
hormone (FSH) secretion, leading to reduced ovarian production of
the sex hormones, estradiol and progesterone, while on therapy.
Elagolix is currently being investigated in diseases that are
mediated by sex hormones, such as uterine fibroids and
endometriosis. To date, elagolix has been studied in over 40
clinical trials totaling more than 3,000 subjects. Phase 3 trials
of elagolix for the management of uterine fibroids are ongoing.
About AbbVie
AbbVie is a global, research-based
biopharmaceutical company formed in 2013 following separation from
Abbott Laboratories. The company's mission is to use its expertise,
dedicated people and unique approach to innovation to develop and
market advanced therapies that address some of the world's most
complex and serious diseases. Together with its wholly-owned
subsidiary, Pharmacyclics, AbbVie employs approximately 29,000
people worldwide and markets medicines in more than 170 countries.
For further information on the company and its people, portfolio
and commitments, please visit www.abbvie.com. Follow @abbvie on
Twitter or view careers on our Facebook or LinkedIn page.
Forward-Looking Statements
Some statements in this
news release may be forward-looking statements for purposes of the
Private Securities Litigation Reform Act of 1995. The words
"believe," "expect," "anticipate," "project" and similar
expressions, among others, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements
are subject to risks and uncertainties that may cause actual
results to differ materially from those indicated in the
forward-looking statements. Such risks and uncertainties include,
but are not limited to, challenges to intellectual property,
competition from other products, difficulties inherent in the
research and development process, adverse litigation or government
action, and changes to laws and regulations applicable to our
industry. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," in
AbbVie's 2015 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
1 National Women's Health Network: Uterine Fibroids.
https://www.nwhn.org/uterine-fibroids/. Accessed March 31, 2017.
2 The American College of Obstetricians and
Gynecologists: FAQ Uterine Fibroids.
http://www.acog.org/-/media/For-Patients/faq074.pdf?dmc=1&ts=20170329T1658263942.
Accessed March 31, 2017.
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SOURCE AbbVie