NORTH CHICAGO, Ill.,
May 17, 2017 /PRNewswire/
-- AbbVie (NYSE: ABBV), a global biopharmaceutical company, in
cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), today
announced that data from two replicate Phase 3 studies evaluating
the efficacy and safety of elagolix, an investigational, orally
administered gonadotropin-releasing hormone (GnRH) antagonist, in
premenopausal women with endometriosis, will be presented at the
13th World Congress on Endometriosis in Vancouver, Canada. New data highlighting
the effects of two different elagolix doses and dosing regimens on
ovarian sex hormones and ovulation will also be presented.
"Endometriosis is associated with painful symptoms that can be
debilitating and there have been few recent medical advancements
for women suffering from this disease," said Rob Scott, M.D., Vice President, Development and
Chief Medical Officer, AbbVie. "These results highlight the
efficacy and safety profile of elagolix and demonstrate its
potential to be an important treatment option for women suffering
from endometriosis."
AbbVie Oral Presentations:
- Elagolix, an Oral Gonadotropin-Releasing Hormone Antagonist,
for the Management of Endometriosis-Associated Pain: Safety and
Efficacy Results From Two Double-Blind, Randomized,
Placebo-Controlled Studies; Taylor H et al.; Session MS08:
Advances in Medical Treatments; Friday, May
19, 2017; 1:15PM to 3:15PM
PT
- The Effect of Elagolix on Bone Mineral Density: Safety
Results From Two Randomized, Placebo-Controlled Studies in Women
With Endometriosis-Associated Pain; Duan W.R., et
al.; Session MS08: Advances in Medical Treatments;
Friday, May 19, 2017; 1:15PM to 3:15PM PT
- The Effect of Elagolix on the Endometrium: Results From Two
Randomized, Placebo-Controlled Studies in Women With
Endometriosis-Associated Pain (EAP); Lessey B et
al.; Session FC08: Endometrium; Saturday, May20, 2017;
10:45AM to 11:45AM PT
AbbVie Posters:
- Use of Elagolix For the Management of
Endometriosis-Associated Pain: Secondary Efficacy Results From Two
Randomized, Placebo-Controlled Studies; Taylor H et al.;
Poster #PS02-094; Thursday, May 18
and Friday, May 19, 2017;
5:15PM to 6:30PM PT
- Effects of Elagolix, an Oral Gonadotropin-Releasing Hormone
(GNRH) Antagonist, on Gonadotropins and Ovarian Sex Hormones in
Healthy Premenopausal Women; Ng J et al.; Poster
#PS02-003; Thursday, May 18 and
Friday, May 19, 2017; 5:15PM to 6:30PM PT
- Effects of Elagolix, an Oral Gonadotropin-Releasing Hormone
(GNRH) Antagonist, on Ovulation, Ovarian Activity, and Ovarian
Reserve in Healthy Premenopausal Women; Ng J et
al.; Poster #PS02-004; Thursday, May
18 and Friday, May 19, 2017;
5:15PM to 6:30PM PT
- The Effect of Elagolix on Estradiol: Results From Two
Randomized Phase 3 Studies in Women With Endometriosis-Associated
Pain (EAP);Ng J et al.; Poster #PS02-014;
Thursday, May 18 and Friday, May 19, 2017; 5:15PM to 6:30PM PT
About Endometriosis
Endometriosis occurs when tissue
similar to that normally found in the uterus begins to grow outside
of the uterus, leading to long-term pelvic pain (during or between
periods), pain with intercourse and other painful
symptoms.1,2 These growths are called lesions and can
occur on the ovaries, the fallopian tubes, or other areas near the
uterus, such as the bowel or bladder.1,3 There is no
cure for endometriosis,4 and the associated pain is
currently managed with oral contraceptives, progestins, danazol,
nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and GnRH
agonists, many of which are not specifically indicated for the
treatment of endometriosis.5 In more extensive cases,
surgical interventions (e.g., laparotomy or laparoscopy) are often
pursued, and may not be curative for all
individuals.5
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. AbbVie plans to
submit a New Drug Application to the U.S. Food and Drug
Administration (FDA) for endometriosis in 2017. Phase 3 trials of
elagolix for the management of uterine fibroids are ongoing.
About AbbVie
AbbVie is a global, research-driven
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 or LinkedIn.
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 The American College of Obstetricians
and Gynecologists. ACOG Education Pamphlet AP013: Endometriosis.
Washington, DC: September 2008. ISSN 1074-8601.
2 Mayo Clinic. Diseases and Symptoms: Endometriosis Fact
Sheet. http://www.mayoclinic.org/diseases-conditions/endometriosis/basics/symptoms/con-20013968.
Accessed February 1, 2016.
3 MM, Silverberg K, Olive DL. Endometriosis and
Adenomyosis. IN: Copeland LJ, Jarrell JF, eds. Textbook of
Gynecology. 2nd ed. Philadelphia, PA: WB Saunders;
2000:687-722.
4 Nnoaham KE, Hummelshoj L., Webster P, d'Hooghe T, de
Cicco Nardone,F, de Cicco Nardone C,
Jenkinson C, Kennedy SH, Zondervan KT, World Endometriosis Research
Foundation Global Study of Women's Health, consortium. Impact
of endometriosis on quality of life and work productivity: a
multicenter study across ten countries. Fertility and Sterility.
2011:96:366-373.
5 Giudice LC. Clinical practice: Endometriosis. New
England Journal of Medicine. 2010;362:2389–2398.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/abbvie-presents-pivotal-phase-3-data-on-investigational-treatment-elagolix-at-the-world-congress-on-endometriosis-300458986.html
SOURCE AbbVie