Unanimous FDA panel backing for Janssen’s simeprevir for hep C

US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen yesterday announced that the Antiviral Drugs Advisory Committee of the US Food and Drug Administration unanimously (19-0) recommended approval of its investigational protease inhibitor simeprevir (TMC435) administered once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis.

The Advisory Committee recommended the approval of simeprevir based on analyses of data from clinical trials in patients who are treatment-naive or who have failed previous interferon-based therapy. This follows a review released earlier this week by FDA staff that found the once-daily oral protease inhibitor was "generally safe" and effective for most patients infected with hepatitis C virus (HCV).

The panel discussed a recommendation made by FDA staff, and supported by J&J, to screen potential simeprevir patients for a genetic mutation called Q80K polymorphism that renders the drug ineffective.