Medivir AB (MVIRb.F): Regulatory Application Has Now Been Filed for Simeprevir (TMC435) in Japan for the Treatment of Genotype 1 Hepatitis C Patients
2/22/2013 10:05:58 AM
STOCKHOLM--(BUSINESS WIRE)--Regulatory News: Medivir AB (STO:MVIR-B) today announced that its partner Janssen now has submitted a regulatory application to the Japanese Ministry of Health & Welfare authorities seeking approval for simeprevir, administered with pegylated interferon (Peg-IFN) and ribavirin (RBV) for the treatment of genotype 1 chronic hepatitis C patients who are treatment naïve, prior non responders or relapsed following treatment with Peg-IFN with or without RBV. Simeprevir, an investigational NS3/4A protease inhibitor, is administered as a single once-daily pill for 12 weeks.
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