Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for daclatasvir (DCV), a NS5A complex inhibitor, in combination with other agents for the treatment of hepatitis C virus (HCV).
The initial daclatasvir NDA submitted to the FDA focused on its use in combination with asunaprevir, an NS3/4A protease inhibitor. Given the withdrawal of asunaprevir by Bristol-Myers Squibb in October, the FDA is requesting additional data for daclatasvir in combination with other antiviral agents for the treatment of HCV.
Previously the FDA granted the investigational DCV Dual Regimen (DCV+asunaprevir) Breakthrough Therapy Designation. In 2013, the investigational all-oral 3DAA Regimen (daclatasvir/asunaprevir/BMS-791325) also received Breakthrough Therapy Designation.
For more information call (800) 321-1335 or visit BMS.com.