NORTH CHICAGO, Ill.,
April 10, 2018 /PRNewswire/ -- AbbVie
(NYSE:ABBV), a global research and development-based
biopharmaceutical company in cooperation with Neurocrine
Biosciences, Inc. (NASDAQ: NBIX), announced notification by the
U.S. Food and Drug Administration (FDA) that it requires extended
time to review additional information regarding the results of
liver function tests provided by AbbVie in connection with its New
Drug Application (NDA) for elagolix in endometriosis-associated
pain. The Prescription Drug User Fee Act (PDUFA) date has been
extended three months to Q3 2018.
In Q4 2017, the FDA granted priority review for AbbVie's NDA for
endometriosis. The FDA grants priority review to medicines it
determines have potential to provide significant improvements in
the safety and effectiveness of the treatment of a serious disease.
If approved, elagolix will be the first new oral medical management
treatment option for endometriosis-associated pain in more than a
decade.
"Based on our review of the data, we remain confident in our New
Drug Application for elagolix in the treatment of
endometriosis-associated pain," said Michael Severino, M.D., executive vice
president, research and development and chief scientific officer,
AbbVie. "Elagolix has the potential to be an important new
treatment option for women suffering from endometriosis and we are
committed to working with the FDA to bring this therapy to
patients."
The NDA for elagolix 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. Clinical trial data demonstrated
elagolix was well-tolerated and significantly reduced the three
types of endometriosis-associated pain – daily menstrual pelvic
pain, non-menstrual pelvic pain and painful intercourse.
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.
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 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.1,2 Estrogen fuels
the growth of lesions.2 There is no cure for
endometriosis,3 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.2 In more extensive cases, surgical
interventions (e.g., laparotomy or laparoscopy) are often pursued,
and may not be curative for all individuals.4
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.
About Neurocrine Biosciences, Inc.
Neurocrine
Biosciences is a San Diego based biotechnology
company focused on neurologic, psychiatric and endocrine related
disorders. The Company markets
INGREZZA® (valbenazine) capsules in the United
States for the treatment of adults with tardive
dyskinesia. INGREZZA is a novel, selective vesicular monoamine
transporter 2 (VMAT2) inhibitor, and is the
first FDA approved product indicated for the treatment of
adults with tardive dyskinesia. The Company's three late-stage
clinical programs are: elagolix, a gonadotropin-releasing hormone
antagonist for women's health that is partnered with AbbVie
Inc.; opicapone, a novel, once-daily, peripherally-acting,
highly-selective catechol-o-methyltransferase inhibitor under
investigation as adjunct therapy to levodopa in Parkinson's
patients; and INGREZZA, a novel, once-daily, selective VMAT2
inhibitor under investigation for the treatment of Tourette
syndrome.
AbbVie 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.
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1 The
American College of Obstetricians and Gynecologists. ACOG Education
Pamphlet AP013: Endometriosis. Washington, DC: September 2008. ISSN
1074-8601.
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2 Giudice
LC. Clinical practice: Endometriosis. New England Journal of
Medicine. 2010; 362:2389–2398.
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3 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.
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4 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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SOURCE AbbVie