FDA approves Gilead's pan-genotypic HCV combo

FDA approved Epclusa sofosbuvir/velpatasvir from Gilead Sciences Inc. (NASDAQ:GILD) to treat HCV in patients with and without cirrhosis. The agency said the combination is the first regimen it has approved to treat all six HCV genotypes.

Gilead spokesperson Cara Miller told BioCentury that Epclusa's wholesale acquisition cost (WAC) will be $74,760 for a 12-week course. The company expects to launch Epclusa in the U.S. next week. FDA based its approval on the Phase III ASTRAL studies, where Epclusa treatment produced an SVR12 in 98% of genotype 1-6 HCV patients (see BioCentury Extra, Sept. 21, 2015). ...