FDA Approves Janssen’s Olysio To Treat Chronic Hepatitis C Virus Infection

The Food and Drug Administration Nov. 22 approved Olysio (simeprevir), a new therapy to treat chronic hepatitis C virus infection.

Olysio, which is marketed by Raritan, N.J.-based Janssen Pharmaceuticals Inc., is a protease inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate, the agency said. It is to be used as a component of a combination antiviral treatment regimen.

In clinical studies, Olysio was evaluated in combination with peginterferon-alfa and ribavirin, two drugs also used to treat hepatitis C virus infection, the FDA said. Olysio is intended for adults with compensated liver disease (a diseased ...