BioCentury
ARTICLE | Company News

J&J looks to expand Olysio label to include use with Sovaldi

May 7, 2014 11:24 PM UTC

The Janssen Research & Development LLC unit of Johnson & Johnson (NYSE:JNJ) submitted an sNDA to FDA to expand the label of Olysio simeprevir to include its use in combination with Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) to treat HCV. The application covers the use of the drugs in combination for chronic HCV genotype 1 infection in treatment-naive patients with advanced fibrosis and null responders with all stages of liver fibrosis.

J&J markets simeprevir in the U.S. as Olysio, in Canada as Galexos and in Japan and Russia as Sovriad to treat chronic HCV genotype 1 infection in patients with compensated liver disease. In March, EMA's CHMP backed approval for HCV genotypes 1 and 4 infection. J&J has ex-Nordic rights to develop and commercialize the HCV NS3/4A protease inhibitor from Medivir AB (SSE:MVIR B), which was up SEK0.75 to SEK119.75 on Wednesday. ...