June Verdict Expected For Gilead Sofosbuvir/Velpatasvir Combo
This article was originally published in Scrip
Executive Summary
Gilead Sciences Inc. has won a priority review from the FDA for the firm's new drug application (NDA) for its once-daily fixed-dose combination of sofosbuvir (SOF), a nucleotide analogue NS5B polymerase inhibitor, which is marketed as a single agent under the brand name Sovaldi, and velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, as a treatment for chronic hepatitis C virus (HCV).