Janssen Submits NDA for Simeprevir for Chronic Hepatitis C

Janssen Research & Development announced that it has submitted a New Drug Application (NDA) to the FDA seeking approval for simeprevir (TMC435), an investigational NS3/4A protease inhibitor, administered as a 150mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients. Simeprevir is believed to work by blocking the protease enzyme that enables the hepatitis C virus to survive and replicate in host cells.

The submission is supported in part by data from three pivotal Phase 3 studies, QUEST-1 and QUEST-2 in treatment naïve patients and PROMISE in patients who have relapsed after prior interferon-based treatment. In each study, participants were treated with one 150mg simeprevir capsule once daily for 12 weeks plus pegylated interferon and ribavirin for 24 or 48 weeks.

For more information visit www.janssenrnd.com.