Janssen files for European approval of hep C candidate simeprevir

Janssen-Cilag International, a European subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), has submitted a Marketing Authorization Application to the European Medicines Agency seeking approval for simeprevir (TMC435) for the treatment of adult patients with chronic hepatitis C genotype 1 or genotype 4.

Simeprevir is a new generation NS3/4A protease inhibitor, administered as one capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 or genotype 4 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis), with or without HIV-1 co-infection, who are treatment naive or who have failed previous interferon therapy. Genotype 1 is the most prevalent form of hepatitis C virus (HCV) worldwide. Simeprevir is currently in Phase III development.

If approved, people living with HCV would have the option of a new generation protease inhibitor-based regimen that includes simeprevir taken once daily for 12 weeks in combination with 24 or 48 weeks of pegylated interferon and ribavirin, the company noted.