Allergan Gets CHMP Positive Opinion For Truberzi To Treat IBS-D In Adults

(RTTNews) - Allergan plc (AGN) announced that the Committee for Medicinal Products for Human Use or 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.

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.

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.