Gilead submits Japanese NDA for Sovaldi

Gilead Sciences Inc. (NASDAQ:GILD) submitted an NDA to Japan's Ministry of Health, Labor and Welfare (MHLW) for Sovaldi sofosbuvir to treat chronic HCV genotype 2 infection. The company already markets Sovaldi in the U.S., EU and Canada to treat HCV infection.

Gilead is also evaluating a fixed-dose combination of Sovaldi plus ledipasvir in a Japanese Phase III trial to treat chronic HCV genotype 1 infection. Next half, the company plans to submit an NDA in Japan for the combination, which is already under review in the U.S. and EU. Ledipasvir is an HCV NS5A protein inhibitor (see BioCentury Extra, April 7). ...