Gilead submits NDA for pan-genotypic HCV combo

Gilead Sciences Inc. (NASDAQ:GILD) submitted an NDA to FDA for a fixed-dose combination of sofosbuvir/velpatasvir to treat chronic genotype 1-6 HCV infection. The company said the treatment could eliminate the need for HCV genotype testing.

Last month, Gilead released data from four Phase III studies of the combination. The company said it plans to submit an MAA to EMA by YE15 (see BioCentury Extra, Sept. 21). ...