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EC approves J&J's Olysio

May 17, 2014 12:18 AM UTC

The European Commission approved Olysio simeprevir from Johnson & Johnson (NYSE:JNJ) to treat HCV genotypes 1 and 4 infection in combination with peginterferon, ribavirin and/or Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD). J&J and partner Medivir AB (SSE:MVIR B) plan to launch Olysio in the EU next half.

J&J already markets Olysio in the U.S. for HCV genotype 1 infection. Last week, the pharma submitted an sNDA to FDA to expand the U.S. label to include Olysio's use in combination with Sovaldi. J&J also markets the second-generation HCV NS3/4A protease inhibitor as Galexos in Canada and as Sovriad in Japan and Russia for chronic HCV genotype 1 infection (see BioCentury Extra, May 7). ...