US FDA clears first hep C drug in a decade, Merck & Co's Victrelis

In much awaited, though largely expected news, the US Food and Drug Administration on Friday approved pharma giant Merck & Co’s (NYSE: MRK) Victrelis (boceprevir) to treat certain adults with chronic hepatitis C.

Victrelis is used for patients who still have some liver function, and who either have not been previously treated with drug therapy for their hepatitis C or who have failed such treatment. The drug is approved for use in combination with peginterferon alfa and ribavirin, and is the first new treatment approved for hepatitis C in almost 10 years. A bonus as part of the approval is that the FDA has not imposed an onerous Risk Evaluation Mitigation Strategy (REMS) program as had been feared, which could restrict the drug’s sales.

Current standard treatments combine the antiviral drug ribavirin with peginterferon, an immune-boosting protein sold by Merck as PegIntron, which the FDA cleared in 2001, and Switzerland-based Roche) as Pegasys, which the agency approved in 2002.