NORTH CHICAGO, Ill.,
Sept. 6, 2017 /PRNewswire/
-- AbbVie (NYSE: ABBV), a research and development based
global biopharmaceutical company in cooperation with Neurocrine
Biosciences, Inc. (NASDAQ: NBIX), announced that it has submitted a
New Drug Application (NDA) to the U.S. Food and Drug Administration
for elagolix, an investigational, orally administered
gonadotropin-releasing hormone (GnRH) antagonist, being evaluated
for the management of endometriosis with associated pain. In
two replicate Phase 3 clinical studies, elagolix demonstrated
superiority compared to placebo in reducing three types of
endometriosis-associated pain – daily menstrual pelvic pain,
non-menstrual pelvic pain and painful intercourse.
"The submission represents an important step forward for women
suffering from endometriosis and physicians who are in need of
additional medical treatment options to help manage this chronic
and painful disease," said Michael
Severino, M.D., Executive Vice President, Research and
Development and Chief Scientific Officer, AbbVie. "Elagolix has the
potential to be an important oral treatment option for women
suffering from the most prevalent symptoms of endometriosis and we
look forward to working with the FDA throughout the review
process."
The NDA is supported by data from the largest prospective
randomized endometriosis clinical trials conducted to date, which
evaluated the safety and efficacy of elagolix in nearly 1,700 women
with moderate-to-severe endometriosis-associated pain. The data
from two replicate Phase 3 studies demonstrated that, at month
three and month six, both elagolix doses (150 mg once daily and 200
mg twice daily) resulted in a statistically significant higher
proportion of responders for menstrual pain (dysmenorrhea) and
non-menstrual pelvic pain associated with endometriosis as measured
by the Daily Endometriosis Pain Impact scale versus placebo.
Significant improvements compared to placebo were also observed at
month three for the 200 mg twice daily dose in scores for painful
intercourse (dyspareunia). A reduction in the amount and frequency
of rescue pain medication use, including nonsteroidal
anti-inflammatory drugs and opioids, compared to placebo was also
seen in the higher dose at month three and six. In clinical
studies, elagolix treatment decreased endometrial proliferation in
a dose-dependent manner after six months of treatment with no
adverse endometrial findings.
The safety profile of elagolix was consistent with the partial
hormone suppression associated with its mechanism of action.
Findings were consistent across Phase 3 trials and prior elagolix
studies. In the first Phase 3 study, the most frequently reported
adverse events assessed over six months were hot flush, headache
and nausea. The rates for hot flush were (7%, 24%, 42% for
placebo, 150 mg once daily and 200 mg twice daily, respectively)
and headache were (10%, 15%, 17% for placebo, 150 mg once daily and
200 mg twice daily, respectively). The majority of hot flushes were
mild to moderate in severity. Elagolix treatment was associated
with dose-dependent decreases in bone mineral density (BMD) in
women with endometriosis-associated pain. After six months of
treatment, all of the women had a BMD z-score above -2.0, within
the normal age-adjusted range.1,2 The second Phase
3 study demonstrated similar results.
These data were first presented at the American Society for
Reproductive Medicine (ASRM) annual meeting in October 2016 and published in The New
England Journal of Medicine in May
2017.3 Extension studies permitted some women to
be treated for an additional six months, data from which will be
presented at a future meeting.
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.4 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.2,5 Estrogen fuels
the growth of lesions.3 There is no cure for
endometriosis,6 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.3 In more extensive cases, surgical
interventions (e.g., laparotomy or laparoscopy) are often pursued,
and may not be curative for all individuals.7
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 readily 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 submitted
a New Drug Application to the U.S. Food and Drug Administration
(FDA) for the management of endometriosis-associated pain in the
third quarter of 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 @AbbVieUS
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 International Society for Clinical
Densitometry. 2015 ISCD Official Positions – Adult.
https://www.iscd.org/official-positions/2015-iscd-official-positions-adult/.
Accessed August 1, 2017.
2 Data on File, ABV RRTI 64932
3 Taylor, H. S. ,Giudice, L. C., Lessey, B.
A.,Abrao, M. S., Kotarski, J., Archer, D. F., Diamond, M. P.,
Surrey, E., Johnson, N. P., Watts, N. B., Gallagher, J. C., Simon,
J. A., Carr, B. R., Dmowski, W. P., Leyland, N., Rowan, J. P.,
Duan, W. R., Ng, J., Schwefel, B., Thomas, J. W., Jain, R. I.,
Chwalisz, K. Treatment of Endometriosis-Associated Pain with
Elagolix, an Oral GnRH Antagonist. N Engl J Med.
377:28-40, 2017.
4 The American College of Obstetricians and
Gynecologists. ACOG Education Pamphlet AP013: Endometriosis.
Washington, DC: September 2008. ISSN 1074-8601.
5 Giudice LC. Clinical practice: Endometriosis. New
England Journal of Medicine. 2010; 362:2389–2398.
6 Greene, AD, Lang, SA, Kendziorski, JA,
Sroga-Rios, JM, Herzog, TJ, Burns, KA. Endometriosis: where are we
and where are we going? Reproduction. 2016; 152 (3):R63-78.
7 Mayo Clinic. Diseases & Conditions:
Endometriosis Fact
Sheet. http://www.mayoclinic.org/diseases-conditions/endometriosis/diagnosis-treatment/treatment/txc-20236449.
Accessed June 1, 2017.
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