J&J, Medivir Get FDA Approval For Olysio To Treat Hepatitis C Virus Infection

(RTTNews) - Johnson & Johnson (JNJ) and Medivir AB (MVRBF.PK), said they received approval from the U.S. Food and Drug Administration or FDA for its drug, Olysio or simeprevir, a new therapy to treat chronic hepatitis C virus infection. Olysio, which is to be used as a component of a combination antiviral treatment regimen, is a protease inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate. Olysio is intended for adults with compensated liver disease, including cirrhosis, who have not received treatment for their infection, or for whom prior treatment has not been effective. Simeprevir was developed by Medivir and Johnson & Johnson's pharmaceutical division, Janssen Pharmaceutica.

Olysio was studied in combination with peginterferon-alfa and ribavirin, two drugs also used to treat hepatitis C virus infection, in its clincial trials. The safety and effectiveness of Olysio were evaluated in five clinical studies of 2,026 treatment-naive and treatment-experienced participants randomly assigned to receive Olysio plus peginterferon-alfa and ribavirin or placebo plus peginterferon-alfa and ribavirin. Olysio should not be used alone to treat chronic hepatitis C infection.

Olysio was reviewed under the FDA's priority review program, and in 2011, the panel approved Victrelis (boceprevir) and Incivek (telaprevir) for the treatment of hepatitis C. A reduction in Olysio's effectiveness was seen in participants infected with the genotype 1a hepatitis C virus with an NS3 Q80K polymorphism, a strain of the hepatitis C virus commonly found in the United States. Olysio's drug label includes a recommendation to screen for the presence of the strain prior to beginning therapy and to consider alternative therapy if the strain is detected. Olysio is marketed by Janssen Pharmaceuticals, based in Raritan, while Victrelis is marketed by Merck, and Incivek is marketed by Vertex Pharmaceuticals.