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.
"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:
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
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.
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.
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