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.
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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.
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