Gilead Sciences (GILD -1.2%) files a New Drug Application (NDA) with the FDA seeking approval of its once-daily pan-genotypic single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of direct-acting antiviral (DAA)-experienced patients with chronic hepatitis C virus (HCV) infection.
The intended regimen is 12 weeks in DAA-experienced patients with HCV genotypes 1-6 infection without cirrhosis or with compensated cirrhosis. The principal data supporting the submission was generated in two Phase 3s: POLARIS-1 and POLARIS-4. Data from POLARIS-2 and POLARIS-3 also contributed.
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