Priority Review for Gilead's sofosbuvir/NS5A combo

Gilead Sciences Inc. (NASDAQ:GILD) said FDA accepted and granted Priority Review for an NDA for an oral, once-daily, fixed-dose combination of the company's HCV drug Sovaldi sofosbuvir and ledipasvir ( GS-5885) to treat chronic HCV genotype 1 infection. The PDUFA date is Oct. 10. The combination has breakthrough therapy designation in the U.S. An MAA for the combination is under accelerated assessment in the EU.

FDA approved Sovaldi in December, and the European Commission approved the nucleotide analog HCV NS5B polymerase inhibitor in January. Ledipasvir is an HCV NS5A protein inhibitor. ...