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FDA advisors back Merck HCV drug

A committee of outside advisors to the US Food and Drug Administration has voted unanimously in favour of recommending marketing approval for Merck's investigational hepatitis C therapy Victrelis

A committee of outside advisors to the US Food and Drug Administration (FDA) has voted unanimously in favour of recommending marketing approval for Merck's investigational hepatitis C therapy Victrelis (boceprevir), which could become the first new drug for the disease in 20 years. Merck is known as MSD outside the US and Canada.

The FDA's Antiviral Drugs Advisory Committee voted 18-0 that the available data support approval of the HCV protease inhibitor for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 infection in combination with current standard therapy. Genotype 1 is the most common form of the virus in the US and the hardest to treat.

The FDA is not required to follow the recommendations of its advisory committees, but it frequently does so. The agency is aiming to make a decision on the marketing application by mid-May.

The committee's vote followed a review of the phase III clinical study programme for Victrelis, including the clinical trials HCV SPRINT-2 and HCV RESPOND-2, which together enrolled about 1,500 patients with chronic HCV genotype 1 infection. HCV SPRINT-2 enrolled 1,097 treatment-naïve patients, while HCV RESPOND-2 enroled 403 patients who had failed previous therapy.

Results from both studies - 'Boceprevir for Untreated Chronic HCV Genotype 1 Infection' and 'Boceprevir for Previously Treated Chronic HCV Genotype 1 Infection' - were published in the March 31 issue of the New England Journal of Medicine.

Victrelis is an oral therapy that is taken three times a day. Merck acquired the drug as part of its 2009 takeover of Schering-Plough, which had brought the product through phase II development. At a shareholders' meeting shortly afterwards, Peter Kim, president of Merck Research Laboratories, called boceprevir "potentially the most impactful near-term product" in the company's pipeline.

Merck said its ongoing commitment to boceprevir is part of the company's major investment in the field of viral hepatitis, which includes efforts to discover and develop a range of drugs and vaccines for treatment and prevention. The company said it is focusing in particular on developing new oral therapies.

The Antiviral Drugs Advisory Committee will next turn its attention to a discussion of Vertex Pharmaceutical's telaprevir, a possible competitor to Victrelis, on Thursday.

28th April 2011

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