Johnson & Johnson (JNJ) Unit Gets Priority Revenue for Simeprevir NDA
5/14/2013 7:37:31 AM
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Johnson & Johnson (JNJ) unit Janssen Research and Development LLC said the U.S. Food and Drug Administration has granted priority review to its new drug application for simeprevir, its investigational treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease. Simeprevir is an investigational NS3/4A protease inhibitor administered as a 150-milligram capsule once daily with pegylated interferon and ribavirin. Hepatitis C virus is a blood-borne infectious disease of the liver that affects about 3.2 million people in the U.S. The FDA grants priority review to medicines that may offer major advances in care or provide a treatment option where no adequate therapy exists.
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