NORTH CHICAGO, Ill.,
Aug. 5, 2019 /PRNewswire/
-- AbbVie (NYSE: ABBV), a research-based global
biopharmaceutical company, in cooperation with Neurocrine
Biosciences, Inc. (NASDAQ: NBIX), today announced the submission of
a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for elagolix, an investigational, oral
gonadotropin-releasing hormone (GnRH) antagonist, for the
management of heavy menstrual bleeding (HMB) associated with
uterine fibroids in women.
Uterine fibroids are non-cancerous, hormonally-responsive muscle
tissue tumors of the uterus.1 They can affect up to 70%
of Caucasian women and up to 80% of African American women by age
50.2 Fibroids can be asymptomatic but, in some women,
fibroids can cause symptoms, such as heavy menstrual bleeding
(HMB), vaginal bleeding at times other than menstruation, and
anemia.1,3
"This submission brings us closer to our goal of improving care
for women who continue to struggle with the often disruptive
effects of uterine fibroids," said Michael
Severino, M.D., vice chairman and president, AbbVie. "If
approved, this combination has the potential to offer women and
their healthcare providers an additional oral medical treatment
option."
The NDA is supported by data from the elagolix Phase 3 uterine
fibroid program, which evaluated nearly 800 premenopausal women
with HMB associated with uterine fibroids in two pivotal studies
(ELARIS UF-I and ELARIS UF-II) at approximately 100 sites
in the U.S. and Canada. The replicate studies evaluated
the safety, tolerability and efficacy of elagolix alone (300 mg
twice daily, or BID) and in combination with low-dose hormone
(add-back) therapy (estradiol 1.0 mg/norethindrone acetate 0.5 mg)
in women with uterine fibroids for six months. An extension study
permitted women to be treated for an additional six months.
The primary endpoint assessed the reduction in HMB compared to
placebo as measured by the alkaline hematin method, an objective
measurement of total menstrual blood loss (MBL) based on
quantification of menstrual blood collected on sanitary products.
In both studies, elagolix in combination with add back therapy met
the primary endpoint. The most frequent adverse events reported (≥
5 percent) were hot flush, night sweats, nausea, headache and
fatigue.4
Top-line results from these clinical studies were previously
announced at the 47th American Association of Gynecologic
Laparoscopists (AAGL) Global Congress on Minimally Invasive
Gynecology. Detailed results from the Phase 3 program will be
published in a peer-reviewed medical journal later this year.
Elagolix for the management of HMB associated with uterine
fibroids is investigational and its safety and efficacy have not
been evaluated by any regulatory authorities.
About Uterine Fibroids
Uterine fibroids (also called
leiomyomas or myomas) are non-cancerous, hormonally-responsive
muscle tissue tumors of the uterus.1 Fibroids are
the most common type of abnormal growth in a woman's
pelvis1 and can affect up to 70% of Caucasian women
and up to 80% of African American women by age
50.2 Fibroids can range in size, shape, number and
location.1,3 Fibroids can be
asymptomatic but, in some women, they can cause symptoms such as
heavy menstrual bleeding (HMB), vaginal bleeding at times other
than menstruation, anemia, and other symptoms related to women's
health.1,3 Treatment
options for uterine fibroids include surgery (hysterectomy,
myomectomy), endometrial ablation, uterine artery embolization,
magnetic resonance imaging (MRI)-guided ultrasound and medical
management with treatments such as oral contraceptives, progestins,
selective progesterone receptor modulators, and
gonadotropin-releasing hormone (GnRH)
agonists.1,5
About Elagolix
Elagolix is an orally-administered,
nonpeptide, small molecule gonadotropin-releasing hormone (GnRH)
receptor antagonist that inhibits endogenous GnRH signaling by
binding competitively to GnRH receptors in the pituitary
gland.6 Administration results in dose-dependent
suppression of luteinizing hormone (LH) and follicle-stimulating
hormone (FSH), leading to decreased blood concentrations of the
ovarian sex hormones estradiol and
progesterone.6 Elagolix is currently
being investigated in diseases that are mediated by ovarian sex
hormones, such as uterine fibroids and polycystic ovary
syndrome.
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
@abbvie on Twitter, Facebook, LinkedIn or Instagram.
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, competition from
other products, challenges to intellectual property, 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 2018 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 De La Cruz MS, Buchanan EM. Uterine Fibroids:
Diagnosis and Treatment. Am Fam Physician. 2017 Jan
15;95(2):100-107.
2 Baird DD, Dunson DB, Hill MC, Cousins D,
Schectman JM. High cumulative incidence of uterine leiomyoma in
black and white women: ultrasound evidence. Am J Obstet
Gynecol. 2013;188:100-107.
3 The American College of Obstetricians and
Gynecologists: FAQ Uterine Fibroids.
http://www.acog.org/-/media/For-Patients/faq074.pdf?dmc=1&ts=20170329T1658263942.
Accessed May 15, 2019.
4 Data on File at AbbVie, ABVRRTI67252.
5 Alternatives to hysterectomy in the management of
leiomyomas. ACOG Practice Bulletin No. 96. American College of
Obstetricians and Gynecologist. Obstet Gynecol 2008;
112:387-400.
6 Ng J, et al. Dose-Dependent Suppression of
Gonadotropins and Ovarian Hormones by Elagolix in Healthy
Premenopausal Women. J Clin Endocrinol Metab.
2017;102(5):1683-1691
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SOURCE AbbVie