FDA approves Gilead's Harvoni HCV combo

FDA approved Harvoni ledipasvir/ sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD), the first oral combination therapy to treat chronic HCV genotype 1 infection that does not require interferon or ribavirin.

Harvoni is a once-daily, fixed-dose combination of 90 mg of the HCV NS5A protein inhibitor ledipasvir, plus 400 mg of Gilead's nucleotide analog HCV NS5B polymerase inhibitor Sovaldi sofosbuvir. FDA designated Harvoni as a new chemical entity with exclusivity through Oct. 10, 2019. ...