Medivir AB (MVIRb.F): FDA Grants Priority Review to Simeprevir for Combination Treatment of Genotype 1 Chronic Hepatitis C
5/13/2013 11:13:51 AM
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STOCKHOLM--(BUSINESS WIRE)--Regulatory News: Medivir AB (STO:MVIR-B) today announces that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) by Janssen for simeprevir (TMC435), an investigational NS3/4A protease inhibitor administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease.
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