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April 27, 2011

US Committee Backs Merck’s Hepatitis C Drug

A US advisory committee for the Food and Drug Administration (FDA) has voted unanimously to support the approval of Merck's Victrelis (boceprevir) for the treatment of chronic hepatitis C. Victrelis is one of a new class of medicines known as hepatitis C virus protease inhibitors being

By cms admin

A US advisory committee for the Food and Drug Administration (FDA) has voted unanimously to support the approval of Merck’s Victrelis (boceprevir) for the treatment of chronic hepatitis C.

Victrelis is one of a new class of medicines known as hepatitis C virus protease inhibitors being evaluated by the FDA.

The FDA’s Antiviral Drugs Advisory Committee voted 18-0 to back the drug to be used in combination with other hepatitis medicines, pegylated interferon and ribavirin, reports the Wall Street Journal.

Merck Research Laboratories president Peter Kim said, “The positive recommendation brings us one step closer to bringing Victrelis to men and women who need it, and reinforces our ongoing commitment to developing innovative therapies to treat chronic hepatitis C.

“We’re pleased with the panel’s decision and look forward to working with the FDA as it continues to evaluate the application for Victrelis.”

Prior to the vote, the panel reviewed the results from Merck’s Phase III clinical study programme for the treatment, which included around 1,500 patients with chronic hepatitis C genotype 1 infection, the most common form of the virus in the US and most difficult to treat.

The study, published in the New England Journal of Medicine last month showed that among two groups of patients who took the three-drug combination, 59% and 66% were cured of virus, compared to 21% in the control group, who took the two drugs only.

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