FDA approves J&J's Olysio for hepatitis C

Drug intended for use with ribavirin, pegylated interferon

TITUSVILLE, N.J. — The Food and Drug Administration has approved a new treatment made by Johnson & Johnson for hepatitis C, the drug maker said.

J&J subsidiary Janssen Therapeutics announced the approval of Olysio (simeprevir) for treatment of chronic hepatitis C in combination with the drug ribavirin and biotech drugs called pegylated interferons. The drug is meant for adults with HCV genotype 1 with compensated liver disease, including cirrhosis. The company said the drug may benefit patients who have the chronic form of the disease, including those who have not received treatment before or who have failed prior interferon-based therapy.

"Given the complexity of the condition, Olysio was studied in a number of different patient populations, including individuals who have relapsed or failed to respond to previous treatments," Olysio clinical trial investigator and Mount Sinai School of Medicine professor Douglas Dieterich said. "The FDA approval of Olysio is an important milestone for people living with chronic hepatitis C, as it means that patients have a new treatment option with the potential to cure this challenging disease."


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