Sofosbuvir regulatory update

Gilead submitted an NDA to FDA for an oral, once-daily, fixed-dose combination of the company's Sovaldi sofosbuvir and ledipasvir 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 (see BioCentury, Dec. 23, 2013). The company plans to submit an MAA to EMA for the fixed-dose combination this quarter. ...