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Experimental HCV protease inhibitor to receive fast track approval
Michael Carter, Thursday, February 02, 2006
An experimental oral protease inhibitor for the treatment of hepatitis C virus has been granted fast track designation by the United States' Food and Drug Administration (FDA), the organisation that approves medicines for use in the US. The investigational drug, Schering-Plough’s SCH 503034, is currently in Phase II clinical trials.

Fast track designation enables the FDA to speed up the approval of medicines that have been shown to have the potential to meet an unmet medical need.

It is proposed that SCH 503034 will first be used to treat individuals with hepatitis C virus genotype 1 who have not responded to the current standard of care, pegylated interferon and ribavirin. Genotype 1 is the hardest of the hepatitis C genotypes to treat and those with this genotype who fail treatment with the current standard of care have very limited therapeutic options

Phase 1 clinical studies showed that the drug had a powerful anti-hepatitis C effect and was well tolerated when used as monotherapy or in combination with pegylated interferon. Phase II studies are currently underway involving 300 individuals. The phase II study is designed to examine the safety and effectiveness of different doses of SCH 503034 in individuals with hepatitis C genotype 1 who previously failed to respond to therapy with pegylated interferon and ribavirin. All the patients in this study are also being treated with pegylated interferon and some are also receiving ribavirin therapy.

Recently, Vertex Pharmaceuticals announced encouraging results from Phase IB trials for its oral hepatitis C protease inhibitor, VX-950, which has now progressed to larger Phase II studies.