FOSTER CITY (dpa-AFX) - Gilead Sciences, Inc. (GILD) announced it has submitted a New Drug Application (NDA) to the U.S. FDA for an investigational, once-daily single tablet regimen containing sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of direct-acting antiviral-experienced chronic hepatitis C virus-infected patients. The company said the data submitted in the NDA support the use of the regimen for 12 weeks in DAA-experienced patients with genotype 1 to 6 HCV infection without cirrhosis or with compensated cirrhosis.
The NDA for SOF/VEL/VOX is based on data from two Phase 3 studies (POLARIS-1 and POLARIS-4), which evaluated 12 weeks of the fixed-dose combination in DAA-experienced patients with hepatitis C genotypes 1-6, including those who failed prior treatment with an NS5A-containing regimen.The NDA is further supported by two additional Phase 3 studies (POLARIS-2 and POLARIS-3).
The SOF/VEL/VOX fixed-dose combination is an investigational product and its safety and efficacy have not been established. It has been granted Breakthrough Therapy designation by the U.S. FDA for the treatment of chronic genotype 1 HCV patients who have previously failed an NS5A inhibitor-containing regimen.
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