Gilead submits NDA for sofosbuvir/NS5A combo

Gilead Sciences Inc. (NASDAQ:GILD) submitted an NDA to FDA for an oral, once-daily, fixed-dose combination of the company's Sovaldi sofosbuvir and ledipasvir ( GS-5885) to treat chronic HCV genotype 1 infection. The combination has breakthrough therapy designation in the U.S. The submission is based on data from the Phase III ION-1, ION-2 and ION-3 trials, which Gilead reported in December. The company plans to submit an MAA to EMA for the fixed-dose combo this quarter (see BioCentury Extra, Dec. 18, 2013).

FDA approved Sovaldi for HCV infection in December, and the European Commission approved the nucleotide analog HCV NS5B polymerase inhibitor last month. Ledipasvir is an HCV NS5A protein inhibitor (see BioCentury Extra, Jan. 17). ...