US FDA clears new indications for hepatitis C combo drug Harvoni

13 November 2015

The US Food and Drug Administration has approved biotech giant Gilead Sciences’ (Nasdaq: GILD) Harvoni (ledipasvir/sofosbuvir) for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with HIV.

In addition, Harvoni plus ribavirin (RBV) for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis. Harvoni received regulatory approval for the treatment of chronic HCV genotype 1 infection in adults in the USA and Europe in the last quarter of 2014 and generated sales of $3.33 billion in the third quarter of 2015.

Supporting data for approval

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