FDA Approves New Hepatitis C Drugs

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Drug approval could signal new era in Hepatitis C treatment.

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The Food and Drug Administration (FDA) last month approved Merck’s hepatitis C drug, Victrelis. Ten days later, the agency approved a competing hepatitis C drug, Incivek, by Vertex Pharmaceuticals and Johnson & Johnson.

These drugs may now be used by patients who have developed liver diseases, such as cirrhosis, as a result of a hepatitis C infection. As many as 3.9 million individuals in the U.S. are currently infected with hepatitis C, with an estimated 20,000 additional infections each year. These infections often go undetected until serious liver damage has already occurred, yet some previous treatments were unsafe to use on patients with damaged livers.

The market for hepatitis drugs in the United States is expected to grow in light of the FDA’s approvals. However, some individuals with hepatitis C may find themselves unable to afford the new drugs. Incivek is priced at $49,200 for a 12-week treatment, and Victrelis costs $48,400 for a 48-week treatment. The Fair Pricing Coalition criticized both pricing schemes, warning that they will drive up the market rate for similar drugs.

A key committee of the European Medicines Agency has recommended the European Commission approve the marketing of Victrelis, and the makers of Incivek are aiming for European approval by the end of the year.