FDA Approves New Hepatitis C Treatment

The U.S. Food and Drug Administration on Nov. 22 announced the approval of Olysio (simeprevir) to treat chronic hepatitis C virus infection.

The U.S. Food and Drug Administration has approved Olysio (simeprevir) for treatment of chronic hepatitis C virus infection, a disease that can lead to diminished liver function or liver failure. Most people infected with the virus have no symptoms of the disease until liver damage becomes apparent, which may take several years, and most of them then develop chronic hepatitis C. Some will develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice, infections. or liver cancer.

According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with the hepatitis C virus.

Olysio 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 and 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 or for whom previous treatment has not been effective, according to FDA's announcement.

"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," said Dr. Edward Cox, M.D., director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. The others, approved in 2011, are Victrelis (boceprevir) and Incivek (telaprevir).

Olysio was reviewed under FDA's priority review program, which provides for an expedited review of drugs that, if approved, would provide safe and effective therapy when no satisfactory alternative therapy exists or offer significant improvement compared to available therapies.

Olysio is marketed by Janssen Pharmaceuticals, based in Raritan, N.J.; Victrelis is marketed by Whitehouse Station, N.J.-based Merck; and Incivek is marketed by Cambridge, Mass.-based Vertex Pharmaceuticals.

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