Simeprevir Gets Priority Review for Hepatitis C

Janssen R&D announced that the FDA has granted Priority Review for its New Drug Application (NDA) for simeprevir (TMC435), an investigational once daily NS3/4A protease inhibitor in combination with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease, including all stages of liver fibrosis. Simeprevir is administered as a 150mg capsule and works by blocking the protease enzyme that enables the hepatitis C virus to replicate in host cells.

The submission is based on data from three Phase 3 studies, QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in patients who have relapsed after prior interferon-based treatment.

For more information visit