The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Allergan’s Truberzi (eluxadoline) in the European Union (EU) to treat adults with irritable bowel syndrome with diarrhoea (IBS-D).
Truberzi is a twice daily, oral medication used on adult patients suffering from IBS-D.
Allergan chief research and development officer David Nicholson said: “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.
“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.”
Results of two important trials demonstrated that the drug can effectively reduce abdominal pain and diarrhoea, which are the two major symptoms associated with the functional bowel disorder.
University of Leuven Belgium internal medicine professor Jan Tack said: “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.
“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 European Commission is expected to give the final decision for the marketing authorisation of the drug within a few months.
If approved, Allergan is expected to launch this new medicine in Europe next year.