Janssen hepatitis C drug approved by US FDA

Janssen's chronic hepatitis C drug, Olysio, has been approved for use in the United States by the Food and Drug Administation (FDA).

Olysio (simeprevir) is a protease inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate. It is to be used as a component of a combination antiviral treatment regimen. Olysio is intended for adults with compensated liver disease (a diseased liver that is still functioning), including cirrhosis, who have not received treatment for their infection (treatment naïve) or for whom previous treatment has not been effective (treatment experienced).

"Olysio is the third FDA-approved protease inhibitor to treat chronic hepatitis C virus infection, and provides health professionals and patients with a new, effective treatment for this serious disease,"

Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.

Approximately 3.2 million Americans are infected with the hepatitis C virus. The viral disease causes inflammation of the liver that can lead to diminished liver function or liver failure.

Olysio's approval was based on five clinical trials of 2,026 treatment-naïve and treatment-experienced patients, who were randomly assigned to receive Olysio plus peginterferon-alfa and ribavirin or placebo plus peginterferon-alfa and ribavirin. The studies were designed to measure whether a participant's hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response), suggesting a participant's infection had been cured.

Results showed 80 % of treatment-naive participants given Olysio plus peginterferon-alfa and ribavirin achieved sustained virologic response, compared to 50 % of participants receiving peginterferon-alfa and ribavirin alone.