Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has amended a previously granted Breakthrough Therapy designation for the investigational daclatasvir and sofosbuvir combination for use in hepatitis C (HCV) patients. This designation is separate from the FDA’s ongoing New Drug Application (NDA) review of daclatasvir-sofosbuvir regimen for the treatment of patients with genotype 3 HCV.
The updated designation reflects recently presented data on HCV genotype 1 patients with advanced cirrhosis (Child-Pugh Class B or C) and those who develop genotype 1 HCV recurrence post-liver transplant. The designation is supported by data from ALLY-1, a Phase 3 clinical trial evaluating a 12-week regimen of daclatasvir and sofosbuvir once-daily with ribavirin for the treatment of patients with HCV with either advanced cirrhosis or post-liver transplant recurrence of HCV.
Daclatasvir is an investigational NS5A replication complex inhibitor. Sofosbuvir is an HCV NS5B polymerase inhibitor indicated as part of a combination antiviral treatment regimen for chronic hepatitis C (CHC) genotype 1, 2, 3, or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplant), and those with HCV/HIV-1 co-infection.
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