Hepatitis C Drug From Vertex Sails Through Test
May 2, 2011
On Thursday, Vertex Pharmaceutical's new hepatitis C virus treatment gained unanimous support from an independent committee that advises the Food and Drug Administration on antiviral drugs. After a daylong hearing with stakeholders, the committee of medical experts voted 18-0 to recommend FDA approve telaprevir as a new HCV treatment. FDA typically follows the panel's advice and is scheduled to make a decision on May 23.
Telaprevir is administered in combination with standard therapy: pegylated interferon and ribavirin. Of treatment-naïve HCV patients taking the telaprevir combination regimen, 79 percent achieved a sustained virologic response. Standard treatment alone against the same hardest-to-treat HCV strain typically achieves SVR in less than half of patients. Telaprevir works by blocking the protease enzyme HCV needs to replicate.
04.29.2011; Robert Weisman
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