Janssen submits hepatitis C drug candidate Simeprevir for FDA approval

04/2/2013 | Pharmaceutical Business Review Online

Janssen Research & Development filed a new drug application with the FDA for approval to use its NS3/4A protease inhibitor Simeprevir, or TMC435, with pegylated interferon and ribavirin as a treatment for genotype 1 chronic hepatitis C. The application was based on results of late-stage trials involving previously untreated and treatment-experienced patients with compensated liver disease.

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