Gilead Sciences announced that the Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for an investigational, once-daily fixed-dose combination for the treatment of chronic genotype 1–6 hepatitis C virus (HCV) infection. The treatment combines the nucleotide analog polymerase inhibitor, sofosbuvir (SOF [Sovaldi]), and velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor.
The FDA has granted SOF/VEL a Breakthrough Therapy designation. The NDA for SOF/VEL is supported by data from four Phase 3 ASTRAL trials, which evaluated the fixed-dose combination in hepatitis C genotypes 1–6. The SOF/VEL fixed-dose combination is an investigational product and its safety and efficacy have not been established.