Gilead Completes HCV Clinical Development With Vosevi Approval

Gilead Sciences Inc. obtained US approval – about three weeks ahead of an Aug. 8 user fee date – for its final hepatitis C product incorporating the nucleoside polymerase inhibitor sofosbuvir as the US FDA okayed Vosevi (sofosbuvir/velpatasvir/voxilaprevir) July 18 as a treatment for HCV-infected patients who have failed prior therapy with a direct-acting antiviral regimen.

With the Foster City, Calif.-based firm earlier this year slashing sales guidance for its HCV franchise, the Vosevi approval can be seen as virtually the end of an era for the virology powerhouse, which has not quite figured out its future direction. (Also see "Nearing Finish Line, HCV Race Focuses On Salvage Therapy" - Scrip, 24 November, 2016