NORTH CHICAGO, Ill.,
March 13, 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-II study (M12-817) of elagolix met its primary endpoint. Results
from the second of two pivotal Phase 3 studies demonstrated at
month six that elagolix (300 mg twice daily), in combination with
low-dose hormone (add-back) therapy (estradiol 1.0 mg /
norethindrone acetate 0.5 mg), reduced heavy menstrual bleeding
with 76.2 percent (p<0.001) of women with uterine fibroids
achieving clinical response compared to placebo (10.1 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<0.02) at month
six.1
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
50.2 Fibroids can be asymptomatic, but in approximately
25 percent of women3, fibroids can cause symptoms, such
as heavy menstrual bleeding, painful periods, vaginal bleeding at
times other than menstruation, and anemia.2 African
American women are more likely to experience fibroids and do so at
a younger age.4
"Millions of women currently diagnosed with uterine fibroids are
faced with limited non-surgical options," said Dawn Carlson, M.D., M.P.H., vice president,
general medicine development. "The results from this study
demonstrate elagolix has the potential to be an important oral
treatment option for women suffering from uterine fibroids."
Hypoestrogenic effects, such as hot flush and reduction in bone
mineral density, from elagolix treatment were observed in the
study. The overall safety profile for elagolix was consistent with
what was observed in Phase 2 studies and the first Phase 3 study
(ELARIS UF-I) in uterine fibroids.1,5-6 Data from the
ELARIS UF-II Phase 3 study will support regulatory submissions for
elagolix. Safety data, including most common adverse events,
continue to be collected in this ongoing study.
The topline results from this six-month primary analysis were
consistent with topline results from the ELARIS UF-I study reported
in February 2018 and will be
presented at an upcoming medical conference. 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.3 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 50.2 Fibroids can
range in size, shape, number and location.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, anemia, pain in
the abdomen or lower back, pain during sex, difficulty urinating or
frequent urination, constipation, rectal pain or difficulty getting
pregnant.2 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.2
About Study Design
ELARIS UF-II is the second of two replicate, pivotal, six-month
Phase 3 studies evaluating the safety, tolerability and efficacy of
elagolix alone (300 mg twice daily) and in combination with
low-dose hormone (add-back) therapy (estradiol 1.0 mg /
norethindrone acetate 0.5 mg), 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 100 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 Data on File, ABVRRTI65900
2 National Women's Health Network: Uterine
Fibroids. https://www.nwhn.org/uterine-fibroids/. Accessed
March 31, 2017.
3 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.
4 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.
5 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.
6 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.
View original content with
multimedia:http://www.prnewswire.com/news-releases/abbvie-announces-positive-topline-results-from-second-phase-3-study-evaluating-investigational-elagolix-in-women-with-uterine-fibroids-300612741.html
SOURCE AbbVie