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FDA Advisory Committee Recommends Approval of Medivir AB's Simeprevir for Combination Treatment of Genotype 1 Chronic Hepatitis C in Adult Patients

Thursday, 24 Oct 2013 04:10pm EDT 

Medivir AB announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 19 to 0 to recommend approval of the investigational protease inhibitor simeprevir (TMC435) 150 mg capsules administered once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis. The Advisory Committee recommended the approval of simeprevir based on analyses of data from clinical trials in patients who are treatment-na├»ve or who have failed previous interferon-based therapy. 

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