FDA Committee Recommends Approval of Simeprevir for Hepatitis C

Oct 25, 2013

The Sacramento Bee

Janssen Research & Development announced that an advisory committee to the FDA voted unanimously to recommend approval of the investigational protease inhibitor simeprevir (TMC435) administered with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis. The 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. Read the full story