EC grants marketing authorisation for Aptalis’s Truberzi to treat IBS-D

22 September 2016 (Last Updated September 22nd, 2016 18:30)

The European Commission (EC) has granted marketing authorisation for Aptalis’s Truberzi (eluxadoline) in Europe.

The European Commission (EC) has granted marketing authorisation for Aptalis’s Truberzi (eluxadoline) in Europe.

Rights to the drug will shortly be transferred back to Allergan, following the sale of Aptalis, previously an Allergan company, to Teva. 

Truberzi is an oral medication that offers sustained relief from multiple symptoms of irritable bowel syndrome with diarrhoea (IBS-D) in adults.

With this authorisation, the drug is now approved for use in the 28 countries of the European Union, as well as in Norway, Iceland and Liechtenstein.

In two pivotal Phase III trials, Truberzi demonstrated a reduction in two symptoms of IBS-D, abdominal pain and diarrhoea.

"The European approval of Truberzi as the only licensed treatment for IBS-D is a welcome new treatment option for patients in Europe."

Allergan Specialist Care international strategic marketing vice-president Christian Szita said: “IBS with diarrhoea can have a significant impact on patients, and there is a real need for treatment options that help these patients regain control of their lives.

“Making Truberzi available across Europe to treat the most bothersome symptoms of IBS-D forms part of our commitment to building a strong partnership with the gastrointestinal community.”

IBS is estimated to affect around 11% of people more than 15 years old and about one third of these are thought to have IBS-D.

A pan-European survey has found that about 3.5 million people across western European countries are expected to have IBS-D.

University of Leuven internal medicine professor Jan Tack said: “IBS-D can have a significant and profound impact on patient quality of life, often manifested through dietary restrictions, emotional distress and activity limitations.

“The European approval of Truberzi as the only licensed treatment for IBS-D is a welcome new treatment option for patients in Europe.”

Allergan hopes to launch the new product in Europe next year.