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Priority Review Granted to Hep C Drug Simeprevir

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Due to positive results from three Phase III trials, the FDA has granted a priority review to simeprevir, a Hepatitis C protease inhibitor that is administered with interferon and ribavirin therapy.

Simeprevir Given Priority Review Status By FDA For Hepatitis C Treatment

With stunning results in Phase III clinical trials, the hepatitis C drug is now on a fast track for FDA approval.

By Jonathan Weiss | May 13, 2013

Following previous hepatitis C treatments that were given expedited U.S. Food and Drug Administration (FDA) approval processes and breakthrough status designations, Janssen and Medivir’s jointly developed simeprevir has been given priority review status by the FDA, Medivir announced today. Priority reviews have historically reduced the approval process time by half and are given to drugs that have evidence of increased effectiveness, prevention, or diagnoses of a disease.

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http://www.medicaldaily.com/articles/15454/20130513/simeprevir-fda-hepatitis-c-hepatitis-c-drug.htm

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