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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.


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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