FDA grants priority review for Gilead's ledipasvir/sofosbuvir FDC
This article was originally published in Scrip
Executive Summary
If all goes well, Gilead Sciences could have approval from the FDA by 10 October for the company's once-daily fixed-dose combination (FDC) of ledipasvir, an the NS5A inhibitor, and sofosbuvir, a the nucleotide analog polymerase inhibitor, as a treatment for adults with chronic hepatitis C virus (HCV) genotype 1 infection.