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Merck’s Victrelis approved by FDA

Monday, May 16, 2011 12:50 PM

Merck’s new hepatitis C drug Victrelis has received FDA approval according to Pharma Times. The approval is based on two phase III trials with 1,500 adults.

Victrelis (boceprevir) has been approved for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin. It will be available for adults with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.

While Victrelis’s side effects such as anemia were a concern prior to approval, Edward Cox, director at the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, noted that "this new medication provides an effective treatment for a serious disease, and offers a greater chance of cure for some patients’ hepatitis C infection compared to currently available therapy.”

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