FDA places hold on alisporivir Phase III trial

FDA placed a clinical hold on a Phase III trial of alisporivir just as Novartis AG (NYSE:NVS; SIX:NOVN) reported positive Phase II data for the HCV compound Thursday at the European Association for the Study of the Liver meeting in Barcelona. The hold followed the death of one patient at a trial center in Thailand. According to the pharma, the cause is still being determined, but pancreatitis is listed as a contributor. Novartis said the death was the first and only fatality in the overall alisporivir clinical program, which includes almost 1,800 patients. The trial was evaluating alisporivir plus peginterferon alfa-2a and ribavirin in treatment-naive patients with HCV genotype 1 infection.

Novartis said alisporivir plus peginterferon alfa-2a and ribavirin met the primary endpoint of complete early virologic response (cEVR) vs. peginterferon alfa-2a and ribavirin alone in the Phase II FUNDAMENTAL (A2210) trial in 461 patients with chronic HCV genotype 1 infection. ...