NORTH CHICAGO, Ill.,
Oct. 27, 2017 /PRNewswire/ -- AbbVie
(NYSE:ABBV), a research and development based global
biopharmaceutical company in cooperation with Neurocrine
Biosciences, Inc. (NASDAQ: NBIX), today announced that the U.S.
Food and Drug Administration (FDA) has granted priority review for
elagolix, an investigational, orally administered
gonadotropin-releasing hormone (GnRH) antagonist, being
investigated for the management of endometriosis with associated
pain. The FDA grants priority review to medicines that it
determines have potential to provide significant improvements in
the safety and effectiveness of the treatment of a serious
disease1. AbbVie expects the Prescription Drug
User Fee Act (PDUFA) date for the FDA to complete its review will
be in Q2 2018.
"We are pleased that elagolix has been granted priority review
by the FDA and will continue to work closely with the agency to
hopefully bring this treatment to women suffering from
endometriosis as soon as possible," said Michael Severino, M.D., executive vice
president, research and development and chief scientific officer,
AbbVie.
The NDA is supported by data from the largest prospective
randomized clinical trials conducted to date for
endometriosis. The safety and efficacy of elagolix were
evaluated in nearly 1,700 women with moderate-to-severe
endometriosis-associated pain.
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 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 trials totaling more than 3,000 subjects. The FDA granted
priority review for AbbVie's NDA for endometriosis in Q4 2017.
Phase 3 trials of elagolix for the management of uterine fibroids
are ongoing.
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.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.2,3 Estrogen fuels
the growth of lesions.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.3 In more extensive cases, surgical
interventions (e.g., laparotomy or laparoscopy) are often pursued,
and may not be curative for all individuals.5
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 U.S. Food and Drug Administration. Priority Review.
http://www.fda.gov/ForPatients/Approvals/Fast/ucm405405.htm.
Accessed September 29, 2017.
2 The American College of Obstetricians and
Gynecologists. ACOG Education Pamphlet AP013: Endometriosis.
Washington, DC: September 2008. ISSN 1074-8601.
3 Giudice LC. Clinical practice: Endometriosis. New
England Journal of Medicine. 2010; 362:2389–2398.
4 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.
5 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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