DUBLIN, July 25, 2016 /PRNewswire/ -- Allergan plc
(NYSE: AGN), a leading global pharmaceutical company, today
announced that the Committee for Medicinal Products for Human Use
(CHMP) has adopted a Positive Opinion for TRUBERZI® (eluxadoline)
in the European Union.4 TRUBERZI® is an oral medication
that relieves the main symptoms of irritable bowel syndrome with
diarrhoea (IBS-D) in adults.1 In two pivotal
trials, TRUBERZI® significantly reduced two of the most
bothersome symptoms of IBS-D, abdominal pain and diarrhoea, with
sustained relief demonstrated over six months1,2.
TRUBERZI® was generally well tolerated with the most common
side effects being nausea, constipation, and abdominal
pain1,2.
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"With this positive decision for TRUBERZI®, Allergan is one step
closer to bringing this innovative medication to IBS-D patients
across Europe who are in desperate
need of new treatment options," said David
Nicholson, Chief R&D Officer, Allergan. "Once approved,
TRUBERZI® will join CONSTELLA® (linaclotide) as the only licensed
prescription medications proven to treat bothersome symptoms of
IBS-D and irritable bowel syndrome with constipation (IBS-C)
respectively. Offering these effective treatment options to
physicians and their patients underscores Allergan's commitment to
helping address unmet needs in gastrointestinal diseases."
IBS is common worldwide, with an estimated global prevalence of
around 11%.5,6 Around one third of IBS patients are
estimated to have IBS-D.7 In a pan-European survey, it
is estimated that approximately 3.5 million people (1.4% of the
population) across western European countries have IBS-D
(France, Germany, Italy, Spain,
and the UK).8 IBS is associated with a high economic
burden in terms of direct medical costs and intangible social
costs.9 In the European Union, total costs (direct and
intangible social costs) are estimated to be between €700–€1600 per
person per year,10 but the true economic and human
impact of managing IBS is widely
underestimated.11-14
"IBS-D can severely affect patient quality of life and in some
cases it can be very debilitating. In the absence of effective
medications, doctors and patients have had few options available
beyond over-the-counter medicines, as well as diet and lifestyle
modifications," said Prof. Jan Tack,
Professor of Internal Medicine at the University of Leuven,
Belgium. "TRUBERZI® has the
potential to become the only licensed treatment for IBS-D in
Europe providing a valuable,
evidence-based treatment option for patients."
The CHMP is the scientific committee of the European Medicines
Agency (EMA) and recommends medicines for Marketing Authorisation
across the 28 member states of the European Union. The final
decision from the European Commission is expected within a few
months. If approved, Allergan anticipate launching this new product
in Europe during 2017, following
successful negotiations with the relevant national payer and
reimbursement groups.
Note to Editors:
About TRUBERZI®
TRUBERZI® (eluxadoline) is a twice daily, oral medication
indicated for use in adults suffering from irritable bowel syndrome
with diarrhoea (IBS-D).1 TRUBERZI® has a novel dual
mechanism of action and acts on both agonist-antagonist opioid
receptors in the gastrointestinal tract.1 TRUBERZI®
effectively targets multiple symptoms of IBS-D, such as pain,
diarrhoea, urgency and bloating.1,2 TRUBERZI® is already
licensed in the U.S. as VIBERZI™.
About Irritable Bowel Syndrome with Diarrhoea (IBS-D)
IBS-D is a functional bowel disorder characterised by chronic
abdominal pain and frequent diarrhoea. The exact causes of IBS-D
are unknown but symptoms are thought to result from a disturbance
in the way the gastrointestinal tract and nervous system
interact.
IBS-D can be debilitating and there are limited therapeutic
options for managing the chronic symptoms. IBS-D is associated with
economic burden in direct medical costs and intangible social
costs, such as work absenteeism and lost productivity, along with
decreased patient quality of life.8,12-15
About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin,
Ireland, is a unique, global
pharmaceutical company and a leader in a new industry model –
Growth Pharma. Allergan is focused on developing,
manufacturing and commercialising innovative branded
pharmaceuticals, high-quality generic and over-the-counter
medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that
provide valuable treatments for the central nervous system, eye
care, medical aesthetics, gastroenterology, women's health,
urology, cardiovascular and anti-infective therapeutic categories,
and operates the world's third-largest global generics business,
providing patients around the globe with increased access to
affordable, high-quality medicines. Allergan is an
industry leader in research and development, with one of the
broadest development pipelines in the pharmaceutical industry and a
leading position in the submission of generic product applications
globally.
With commercial operations in approximately 100
countries, Allergan is committed to working with
physicians, healthcare providers and patients to deliver innovative
and meaningful treatments that help people around the world live
longer, healthier lives.
Forward-Looking Statement
Statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements
that reflect Allergan's current perspective of existing
trends and information as of the date of this release. Except as
expressly required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements. Actual
results may differ materially from Allergan's current
expectations depending upon a number of factors
affecting Allergan's business. These factors include,
among others, the difficulty of predicting the timing or outcome
of FDA approvals or actions, if any; the impact of
competitive products and pricing; market acceptance of and
continued demand for Allergan's products; difficulties or
delays in manufacturing; and other risks and uncertainties detailed
in Allergan's periodic public filings with
the Securities and Exchange Commission, including but not
limited to Allergan's Annual Report on Form 10-K for the
year ended December 31, 2015 and Quarterly Report on Form
10-Q for the quarter ended March 31, 2016 (such periodic
public filings having been filed under the "Actavis plc" name).
Except as expressly required by law, Allergan disclaims
any intent or obligation to update these forward-looking
statements.
References
- Truberzi® Summary of Product Characteristics, July 2016
- Lembo AJ, et al. Eluxadoline for Irritable Bowel Syndrome with
Diarrhea. N Engl J Med 2016; 374:242-253
- European Medicines Agency website. Available at:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/general/general_content_000219.jsp
[last accessed: July 2016]
- Committee for Medicinal Products for Human Use (CHMP) Meeting.
European Medicines Agency, London,
UK 22 July 2016. Positive opinion decision available
at:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/07/news_detail_002571.jsp&mid=WC0b01ac058004d5c1
- Canavan C, et al. The epidemiology of irritable bowel syndrome.
Clin Epidemiol 2014;6:71-80.
- Lovell RM, et al. Global prevalence of and risk factors for
irritable bowel syndrome: a meta-analysis. Clin Gastroenterol
Hepatol 2012;10(7):712–21.
- Spiller R, Aziz Q, Creed F, Emmanuel A, Houghton L, Hungin P,
et al. Guidelines on the irritable bowel syndrome: mechanisms and
practical management. Gut. 2007;56(12):1770-98.
- Allergan Data on File INT/0207/2016d June 2016
- Canavan C, et al. Review article: the economic impact of the
irritable bowel syndrome. Aliment Pharmacol Ther
2014;40(9):1023–34.
- Ricci, J-F. Irritable bowel syndrome: a comparison of the
economic (direct and indirect) burden in four European countries.
Gut 2002;51(Suppl 3):Abstract 107.
- Lacy BE, et al. Bowel Disorders. Gastroenterology
2016;150:1393–1407
- Camilleri M, et al. Economic burden of irritable bowel syndrome
proposed strategies to control expenditures.
Pharmacoeconomics 2000;(17)4:331–8.
- Cash B, et al. Total Costs of IBS: Employer and Managed Care
Perspective. Am J Manag Care 2005 Apr;11(1
Suppl):S7–16.
- Volmer T, et al. Cost of illness studies may largely
underestimate the cost of diseases with unmet medical need such as
irritable bowel syndrome (IBS). Value Health
1999;2(5):399–399.
CONTACTS:
Allergan
Investors:
Lisa
DeFrancesco
(862) 261-7152
Media:
Janet Kettels
(Int'l)
+447738506476
Mark Marmur (U.S.)
(862) 261-7558
Aptalis Pharma SAS is the applicant of the marketing
authorisation for Truberzi. Aptalis Pharma SAS is a subsidiary of
Allergan plc.
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SOURCE Allergan plc