FDA priority review status for Gilead's sofosbuvir/velpatasvir for hepatitis C

5 January 2016

US biotech major Gilead Sciences (Nasdaq: GILD) says that the US Food and Drug Administration has granted priority review to the company’s New Drug Application for an investigational, once-daily fixed-dose combination of its already approved Sovaldi (sofosbuvir; SOF) and velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.

Gilead filed the NDA for SOF/VEL on October 28, 2015, and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28, 2016.

Combo dubbed “clear winner” by analyst

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