Gilead Sciences, Inc. GILD today announced that its Marketing
Authorization Application (MAA) for an investigational, once-daily
fixed-dose combination of the nucleotide analog polymerase inhibitor
sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an investigational
pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C
virus (HCV) infection, has been fully validated and is now under
assessment by the European Medicines Agency (EMA). The data included in
the application, which was submitted on November 17, 2015, support the
use of SOF/VEL among patients with genotype 1-6 HCV infection, including
patients with compensated and decompensated cirrhosis.
"Despite advances in the treatment of HCV, there is a need for simple,
highly effective pan-genotypic therapies, particularly
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