CHMP recommends Gilead's HCV combo

EMA's CHMP recommended marketing authorization for Harvoni sofosbuvir/ledipasvir from Gilead Sciences Inc. (NASDAQ:GILD) to treat chronic HCV infection in adults. Gilead expects a final decision from the European Commission by year end.

The oral, once-daily therapy is a fixed-dose combination comprising 400 mg of Sovaldi sofosbuvir, Gilead's blockbuster HCV NS5B polymerase inhibitor, plus 90 mg of ledipasvir, an HCV NS5A protein inhibitor. ...