Priority Review for Olysio/Sovaldi combo

FDA accepted and granted Priority Review to an sNDA from the Janssen Research & Development LLC unit of Johnson & Johnson (NYSE:JNJ) to expand the label of Olysio simeprevir to include its use in combination with Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) to treat chronic HCV genotype 1 infection. The PDUFA date is Nov. 6. The application covers the use of Olysio, a HCV NS3/4A protease inhibitor, and Sovaldi, a nucleotide analog HCV NS5B polymerase inhibitor, in combination in treatment-naive patients with advanced fibrosis and null responders with all stages of liver fibrosis.

Separately, J&J and partner Medivir AB (SSE:MVIR B) reported worldwide 2Q14 Olysio sales of $831 million, including $725 million in U.S. sales. J&J reported $354 million in worldwide 1Q14 sales -- the HCV drug's first full quarter of sales. The pharma launched the drug in the U.S., Canada and Japan in December and plans to launch Olysio in Europe this half. The European Commission approved the drug in May. ...