EMA reviewing Gilead HCV triple combo

Gilead Sciences Inc. (NASDAQ:GILD) said EMA accepted for review an MAA for pan-genotypic HCV combination therapy sofosbuvir/velpatasvir/voxilaprevir to treat chronic HCV infection. Last month, the company submitted an NDA to FDA for the combo to treat chronic HCV genotypes 1-6 in patients who have failed prior treatment with DAA regimens.

The fixed-dose combo includes Sovaldi sofosbuvir, a nucleotide analog HCV NS5B polymerase inhibitor; velpatasvir (GS-5816), a pan-genotypic HCV NS5A protein inhibitor; and voxilaprevir (GS-9857), a pan-genotypic HCV NS3/NS4A protease inhibitor...