FDA expands Harvoni's label

Gilead Sciences Inc. (NASDAQ:GILD) said FDA approved sNDAs for Harvoni ledipasvir/ sofosbuvir to treat patients with HCV genotypes 4, 5, and 6 and patients co-infected with HIV and HCV. The agency also approved Harvoni in combination with ribavirin for 12 weeks in treatment-experienced HCV genotype 1 patients with cirrhosis.

Gilead markets Harvoni to treat HCV genotype 1. The therapy is a fixed-dose combination of Sovaldi sofosbuvir, a nucleotide analog HCV NS5B polymerase inhibitor, and ledipasvir, an HCV NS5A protein inhibitor. ...