Gilead seeks FDA's OK for 'breakthrough' ledipasvir/sofosbuvir combo
This article was originally published in Scrip
Executive Summary
After gaining the FDA's blessing this past December to market Sovaldi (sofosbuvir), a once-daily oral nucleotide analog polymerase inhibitor, for chronic hepatitis C virus (HCV), Gilead Sciences is seeking to win approval of that medicine as part of a fixed-dose combination with ledipasvir, a NS5A inhibitor.