NORTH CHICAGO, Ill.,
Feb. 21, 2018 /PRNewswire/
-- AbbVie (NYSE:ABBV), a global research and development-based
biopharmaceutical company, in cooperation with Neurocrine
Biosciences, Inc. (NASDAQ: NBIX), announced that the Phase 3 ELARIS
UF-I study (M12-815) of elagolix met its primary endpoint. Results
from the first of two pivotal Phase 3 studies demonstrated at month
six that elagolix, in combination with low-dose hormone (add-back)
therapy, reduced heavy menstrual bleeding with 68.5 percent
(p<0.001) of women with uterine fibroids achieving clinical
response compared to placebo (8.7 percent), as measured by the
alkaline hematin method. Clinical response was defined as menstrual
blood loss volume of less than 80 mL during month six and a 50
percent or greater reduction in menstrual blood loss volume from
baseline to month six. The study also met all ranked secondary
endpoints (p<0.001) at month six.4
Uterine fibroids are the most common type of abnormal growth in
a woman's pelvis and can affect up to 80 percent of women by age
50.1 Fibroids can be asymptomatic, but in approximately
25 percent of women2, fibroids can cause symptoms, such
as heavy menstrual bleeding, painful periods, vaginal bleeding at
times other than menstruation, and anemia.1 African
American women are more likely to experience fibroids and do so at
a younger age.3
"Current non-surgical treatments are limited and women suffering
from uterine fibroids need more therapeutic options," said
Dawn Carlson, M.D., M.P.H., vice
president, general medicine development. "The results from this
study represent a significant advancement in the development of
elagolix and demonstrate our continued commitment to address
serious disease."
Hypoestrogenic effects, such as hot flush and reduction in bone
mineral density, from elagolix treatment were observed in the
study. In addition, the overall safety profile for elagolix was
consistent with what was observed in Phase 2 studies in uterine
fibroids.4-6 Data from the Phase 3 study will support
regulatory submissions for elagolix and will be presented at an
upcoming medical conference. Safety data, including most common
adverse events, are currently being analyzed.
The topline results are from a six-month primary analysis. Women
in the study will continue in either post-treatment follow-up or a
blinded six-month extension study.
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 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, some of which
are not specifically indicated for the treatment of uterine
fibroids.1
About Study Design
ELARIS UF-I is the first of two
replicate, pivotal, six-month Phase 3 studies evaluating the
safety, tolerability and efficacy of elagolix alone and in
combination with low-dose hormone (add-back) therapy
(estradiol/norethindrone acetate) in women with uterine
fibroids. Study participants were premenopausal women, age
18–51 years old, with a diagnosis of uterine fibroids documented by
a pelvic transvaginal and transabdominal ultrasound (TAU,
TVU). The primary endpoint assessed the reduction in heavy
menstrual bleeding compared to placebo as measured by the alkaline
hematin method, an objective measurement of total menstrual blood
loss based on quantitation of menstrual blood collected on sanitary
products. Clinical response was defined as menstrual blood loss
volume of less than 80 mL during month six and a 50 percent or
greater reduction in menstrual blood loss volume from baseline to
month six. The ranked secondary endpoints included measures of
bleeding, bleeding suppression and hemoglobin changes. The study
was conducted at approximately 90 sites in the United States and Canada.
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 rapidly reversible, dose-dependent
inhibition of luteinizing hormone (LH) and follicle-stimulating
hormone (FSH) secretion, leading to reduced ovarian production of
the ovarian sex hormones, estradiol and progesterone, while on
therapy. Elagolix is currently being investigated in diseases that
are mediated by ovarian sex hormones, such as uterine fibroids and
endometriosis. To date, elagolix has been studied in over 40
clinical studies, totaling more than 3,700 subjects. Phase 3
studies of elagolix for the management of uterine fibroids are
ongoing.
About AbbVie
AbbVie is a global, research and
development-based biopharmaceutical company committed to developing
innovative advanced therapies for some of the world's most complex
and critical conditions. The company's mission is to use its
expertise, dedicated people and unique approach to innovation to
markedly improve treatments across four primary therapeutic areas:
immunology, oncology, virology and neuroscience. In more than 75
countries, AbbVie employees are working every day to advance health
solutions for people around the world. For more information about
AbbVie, please visit us at www.abbvie.com. Follow @AbbVieUS on
Twitter, Facebook or LinkedIn.
Forward-Looking Statements
Some statements in this
news release are, or may be considered, 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," of AbbVie's 2017 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
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National Women's
Health Network: Uterine Fibroids.
https://www.nwhn.org/uterine-fibroids/. Accessed March 31,
2017.
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2
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Borah BJ, Nicholson
WK, Bradley L, Stewart EA. The impact of uterine leiomyomas: a
national survey of affected women. Am J Obstet Gynecol.
2013;209(4):319.e1–319.e20
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|
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3
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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.Surrey, E., Taylor, H.S., Giudice, L.C.,
Singh, S., Abrao, M.S., Lessey, B.A., Duan, W.R., Peloso P.M.,
Schwefel, B. Chwalisz, K. Long-term safety and efficacy
of elagolix treatment in women with endometriosis associated pain:
primary results from two phase 3 extension studies. Fert.
Sterl. 2017; 108: e95.
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4
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Data on File,
ABVRRTI65780
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5
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Archer, D.F.,
Stewart, E.A., Jain, R.I., Feldman, R.A., Lukes, A.S., North JD,
Soliman, A.M., Gao, J., Ng, J.W., Chwalisz, K. Elagolix for the
management of heavy menstrual bleeding associated with uterine
fibroids: results from a phase 2a proof-of-concept study.
Fert. Sterl. 2017; 108 (1):152-160.e4.
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6
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Stewart EA, Owens C,
Duan R, Gao H, Chwalisz K. Elagolix Treatment in Women with
Heavy Menstrual Bleeding-associated with Uterine Fibroids: Efficacy
and Safety Results from a Phase 2B Study. Poster presented at
American Association of Gynecologic Laproscopists: November
12-16th, 2017. Washington, DC.
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SOURCE AbbVie