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FDA approves Merck HCV drug

The US Food and Drug Administration has approved Merck's hepatitis C therapy Victrelis, making it the first new drug to be cleared for the disease in 20 years

The US Food and Drug Administration (FDA) has approved Merck's hepatitis C therapy Victrelis (boceprevir), making it the first new drug to be cleared for the disease in 20 years. Merck is known as MSD outside the US and Canada.

Specifically, the approved indication covers the treatment of chronic hepatitis C  genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy. The product must not be used as monotherapy, according to the FDA. Genotype 1 is the most common form of the virus in the US and the hardest to treat.

Victrelis is an oral therapy that is taken three times a day with food. Merck acquired the drug as part of its 2009 takeover of Schering-Plough, which had brought the product through phase II development. Compared to current standard therapy, Victrelis can significantly increase the chance of achieving undetectable levels of the virus, sometimes with a shorter total duration of treatment.

The FDA's decision on the product comes shortly after the agency voted unanimously in favour of approval of the HCV protease inhibitor. The panel's recommendation and the agency's approval were based in part on two phase III clinical studies, HCV SPRINT-2 and HCV RESPOND-2, which together enroled about 1,500 patients with chronic HCV genotype 1 infection. HCV SPRINT-2 enroled 1,097 treatment-naïve patients, while HCV RESPOND-2 enrolled 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.

Merck will begin shipping Victrelis to pharmacies within a week. The company will also launch coupons to help eligible patients with their medication cost, reimbursement support to help patients understand their insurance coverage for the drug, and a hotline staffed by nurses.

Meanwhile, Vertex Pharmaceutical is awaiting the FDA's decision on its marketing application for telaprevir, a possible competitor to Victrelis. The Vertex drug also received strong backing from the Antiviral Drugs Advisory Committee.

16th May 2011

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