Priority Review Granted to Hep C Drug Simeprevir
May 15, 2013
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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