BMS Will No Longer Pursue Asunaprevir Approval
Bristol-Myers Squibb announced its withdrawal of the New Drug Application (NDA) for asunaprevir for the treatment of hepatitis C virus (HCV) genotype 1b due to the constant change of the HCV treatment landscape in the United States.
Asunaprevir is an NS3/4A protease inhibitor that was being investigated as dual regimen with daclatasvir, a pan-genotypic NS5A complex inhibitor. The company will continue to pursue the approval of daclatasvir and daclatasvir-based regimens to meet the needs of HCV infection treatment.
Bristol-Myers Squibb plans to submit more data of daclatasvir to the Food and Drug Administration (FDA) in treating patients with HCV genotype 3, patients who are pre- and post-liver transplant, and patients co-infected with HIV.
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