EMA Validates Gilead's Marketing Application for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for Treatment of Hep C

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 See full press release