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Medivir AB announces approval of Simeprevir in USA as new treatment for Hepatitis C


Saturday, 23 Nov 2013 06:00am EST 

Medivir AB:Says that U.S. FDA approved Simeprevir for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease.Says the approval of Simeprevir in the USA is based on several studies of patients with CHC genotype 1 infection.Says these studies include treatment-na├»ve patients (QUEST-1 and QUEST-2), and patients who have failed prior treatment with pegylated interferon and ribavirin; in PROMISE (prior relapsers) and ASPIRE (prior non-responders).Says the USA approval triggers a milestone payment of Euro 10 mln to Medivir.Says Simeprevir is an investigational NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and its affiliated companies and Medivir AB for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including all stages of liver fibrosis. 

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22 Aug 2014