BMS to discontinue Sunvepra (asunaprevir) FDA approval process in US for Hepatitis C.

Given the rapidly evolving Hepatitis C (HCV) treatment landscape in the U.S., Bristol-Myers Squibb has decided that it will not pursue FDA approval of the dual regimen of Daklinza ( daclatasvir) and Sunvepra (asunaprevir) for the treatment of HCV genotype 1b patients in the United States and has therefore withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor. The company will continue to pursue FDA approval of daclatasvir, a potent, pan-genotypic NS5A complex inhibitor (in vitro), which is currently being investigated globally in multiple treatment regimens for HCV patients with high unmet need.