Grazoprevir/elbasvir regulatory update

Merck said FDA granted breakthrough therapy designations to grazoprevir/elbasvir to treat chronic HCV genotype 4 infection and chronic HCV genotype 1 infection in patients with end-stage renal disease (ESRD) on hemodialysis. Merck said it remains on track to submit an NDA this half for the fixed-dose oral combination of grazoprevir, an HCV NS3/4A protease inhibitor, and elbasvir, an HCV NS5A protein inhibitor. ...