IBS-D treatment Truberzi receives positive opinion from CHMP
pharmafile | July 26, 2016 | News story | Manufacturing and Production, Sales and Marketing |Â Â Allergan, EU, Truberzi, diarrhoea. CHMP, irritable bowel syndromeÂ
Global pharmaceutical company Allergan has announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has issued a positive opinion for Truberzi (eluxadoline) in the European Union.
Taken orally, Truberzi relieves the main symptoms of irritable bowel syndrome with diarrhoea (IBS-D) in adults. In trials, the drug was shown to significantly reduce two of the most prominent symptoms of IBS-D, abdominal pain and diarrhoea, over a six month period.
“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,” commented David Nicholson, chief R&D officer at 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 estimated to have a global prevalence of around 11%, with around one third of IBS patients suffering from IBS-D.
“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 Jan Tack, professor of internal medicine at the University of Leuven in 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 final decision from the European Commission is expected within a few months. If approved, Allergan plan to launch Truberzi in Europe in 2017, following successful negotiations with the relevant national payer and reimbursement groups.
Matt Fellows
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