On Oct. 28, 2015, Gilead Sciences (GILD) announced that it has submitted a New Drug Application (NDA) to the FDA for an investigational, once-daily fixed-dose combination of the approved nucleotide analog polymerase inhibitor sofosbuvir (Sovaldi®) abbreviated as (SOF) and the investigational pan-genotypic NS5A inhibitor velpatasvir, abbreviated as (VEL) for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.
The NDA was supported by clinical studies exploring the use of 12 weeks of SOF/VEL for patients with genotype 1-6 HCV infection, including patients with compensated cirrhosis and 12 weeks . . .
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Today’s Highlights January 5, 2016