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U.S., EU Grant Accelerated Reviews of Merck Hepatitis Drug

January 11, 2011

The U.S. Food and Drug Administration (FDA) has granted an accelerated review of Merck & Co.'s experimental hepatitis C drug boceprevir, a status designated for drugs that represent a significant medical advancement or address a public health need.

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Merck said it submitted boceprevir's application to U.S. and EU regulators last year. FDA generally aims to complete reviews of priority applications within six months, compared with the standard 10-month review period.

Another hepatitis C drug, developed by Vertex Pharmaceuticals Inc. and Johnson & Johnson, is also in the pipeline. In December, J&J said the European Medicines Agency had granted an expedited review of telaprevir. However, Vertex, which is handling the FDA application, has not announced a priority review in the United States.

Both drugs are protease inhibitors, which block an enzyme that allows hepatitis C to replicate. While it has been noted that telaprevir has been more effective in clinical trials in curing the infection compared to boceprevir, the two have not been tested head-to-head in the same study.

Standard hepatitis C treatment involves a combination of pegylated interferon and ribavirin. It is hoped that protease inhibitors will boost cure rates, potentially shortening treatment.

Back to other news for January 2011

Excerpted from:
Wall Street Journal
01.06.2011; Peter Loftus




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