Canada approves simeprevir

Medivir AB (SSE:MVIR B) said Health Canada approved a regulatory application from partner Johnson & Johnson (NYSE:JNJ) for simeprevir to treat HCV genotype 1 infection in combination with interferon and ribavirin in patients with compensated liver disease who are treatment-naïve or who failed previous interferon-based therapy with ribavirin. J&J plans to launch the second-generation HCV NS3/4A protease inhibitor in Canada "as soon as possible." In September, Japan approved simeprevir as Sovriad for HCV genotype 1 infection.

Last month, FDA's Antiviral Drugs Advisory Committee unanimously backed approval of simeprevir for HCV genotype 1 infection in adults with compensated liver disease. The specific PDUFA date for simeprevir is not disclosed, but Medivir said it expects a decision by the end of the month. Simeprevir is also under review in the EU (see BioCentury, Nov. 11). ...