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Merck hepatitis C drug gets priority review

Merck has won expedited reviews in both the US and the EU for boceprevir, an investigational oral hepatitis C virus protease inhibitor

Merck has won expedited reviews in both the US and the European Union (EU) for boceprevir, the company's investigational oral hepatitis C virus (HCV) protease inhibitor.

The drug will receive a priority review from the US Food and Drug Administration (FDA), which means that the agency will aim to complete the review in six months rather than the standard 10 months. Priority review status is reserved by the FDA for drugs that have the potential to offer major advances in treatment.

The European Medicines Agency (EMA) will review the drug under its accelerated assessment programme, which is designed for products that address unmet medical needs or represent a significant improvement over available treatments within a major public health interest.

Merck is seeking approval of boceprevir for the treatment of chronic HCV genotype 1 infection, in combination with standard therapy, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.

The company 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 in May, Peter Kim, president of Merck Research Laboratories, called boceprevir "potentially the most impactful near-term product" in the company's pipeline.

However, the drug is likely to receive competition from Vertex Pharmaceutical's telaprevir, a similar therapy for which Vertex completed a rolling new drug application in November. Vertex has requested a priority review for telaprevir, but the FDA has not yet made a decision about whether to grant one.

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.

6th January 2011

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