Through Bristol-Myers Squibbs Early Access Programs in Europe more than 2,000 HCV patients with advanced liver disease have already been treated with Daklinza, in combination with sofosbuvir, said Elliott Levy, Head of Specialty Development, Bristol-Myers Squibb. We anticipate that, if approved, Daklinza-based regimens will play a significant role in treating HCV patients with high unmet medical needs across Europe.

Recently included in the European Association for the Study of the Livers (EASL) clinical practice guidelines for the management of HCV infection across genotypes, the EU marketing authorization application for Daklinza has gone through an accelerated review process. The positive CHMP opinion was based on data from multiple studies ofDaklinza with other HCV agents, including sofosbuvir, for the treatment of chronic hepatitis C.

Applications for Daklinza-based regimens are also pending in Japan and the U.S. A decision from Japans Pharmaceutical and Medical Devices Agency is expected soon, and the U.S. Food and Drug Administration has granted priority review status and set a target review date under the Prescription Drug User Fee Act (PDUFA) of November 30, 2014.

Ongoing and completed Daklinza studies have included more than 5,500 patients in a variety of all-oral regimens and with the current interferon-based standard of care. Across clinical studies, Daklinza-based regimens have been generally well tolerated with low rates of discontinuations across a range of patients.