Allergan plc, a leading global pharmaceutical company, announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a Positive Opinion for Truberzi (eluxadoline) in the European Union.
Truberzi is an oral medication that relieves the main symptoms of irritable bowel syndrome with diarrhoea (IBS-D) in adults. 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 months. Truberzi was generally well tolerated with the most common side effects being nausea, constipation, and abdominal pain.
"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%. Around one third of IBS patients are estimated to have IBS-D. 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). IBS is associated with a high economic burden in terms of direct medical costs and intangible social costs. In the European Union, total costs (direct and intangible social costs) are estimated to be between €700-€1600 per person per year, but the true economic and human impact of managing IBS is widely underestimated.
"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.
Truberzi (eluxadoline) is a twice daily, oral medication indicated for use in adults suffering from irritable bowel syndrome with diarrhoea (IBS-D). Truberzi has a novel dual mechanism of action and acts on both agonist-antagonist opioid receptors in the gastrointestinal tract. Truberzi effectively targets multiple symptoms of IBS-D, such as pain, diarrhoea, urgency and bloating. Truberzi is already licensed in the US as Viberzi.
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.