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Gilead Completes HCV Clinical Development With Vosevi Approval

 
• By Joseph Haas

Bringing three-drug, single-tablet regimen to market means Gilead has an answer for every hepatitis C patient, company says. It still lacks an answer, however, for its future business direction as HCV revenue wanes.

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...

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