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Medivir AB Files New Drug Application with FDA for Simeprevir Developed with Janssen Pharmaceuticals, Inc.


Thursday, 28 Mar 2013 05:15pm EDT 

Medivir AB announced that a new drug application (NDA) has been filed with the US (United States) Food and Drug Administration (FDA) seeking approval for simeprevir. The filing is based on phase III data in treatment-naive and treatment-experienced patients with compensated liver disease. The filing of a regulatory application in the US triggers a milestone payment of EUR 10 million to Medivir. Simeprevir is jointly developed by Medivir and Janssen Pharmaceuticals, Inc. (Janssen), and is an investigational NS3/4A protease inhibitor, administered as a 150 mg (milligrams) capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients. 

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