Alfa Wassermann and Norgine get EU approval for Xifaxan

Italy-based Alfa Wassermann and Netherlands-headquartered Norgine say they have received European Marketing Authorization for Xifaxan 550mg (rifaximin-alpha) - also trade-named  Refero, Targaxan and Ticteller - in the reduction of recurrence of episodes of overt hepatic encephalopathy (HE) in patients ≥ 18 years of age, in a number of European Union territories. First launches in Europe are expected in the first half of 2013.

Rifaximin-alpha, developed by Alfa Wassermann, is currently marketed in many countries worldwide, including the USA in a number of indications. A pivotal trial by Bass and colleagues (2010) demonstrated the efficacy of twice-daily (bid) treatment with Xifaxan 550mg in patients with HE.

Xifaxan is a gut specific antibiotic which targets Gram +ve and Gram -ve ammonia producing aerobes and anaerobes to reduce the plasma ammonia load that is associated with the development of hepatic encephalopathy.