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Vertex recieves FDA approval for Phase III hepatitis drug


CAMBRIDGE, Mass. The Food and Drug Administration has given Cambridge, Mass.-based Vertex Pharmaceuticals approval to begin Phase III trials of an experimental hepatitis C drug, the company announced Tuesday.

Based on results from the Phase III trial, Vertex plans to file an application for approval of the drug, telaprevir, in 2010. It plans to conduct the trials in the United States and Europe Union, putting test subjects on 48-week regimens.

Phase II trials showed that 52 percent of patients form whom other treatments had failed had undetectable levels of hepatitis C virus after using telaprevir for 36 weeks in combination with other drugs.

Hepatitis C affects about 6 million people in the U.S. and E.U., and more than 10 percent of those affected have not responded to standard therapies.

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