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news.Pharmaceutical company Pharmasset has received Fast Track designation from the FDA for its HCV RNA polymerase inhibitor for the treatment of chronic hepatitis C virus infection.
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HCV RNA polymerase inhibitor (R7128) is a prodrug of PSI-6130, an oral cytidine nucleoside analog, which is being developed through Pharmasset’s collaboration with Roche. Pharmasset is currently enrolling a 28-day Phase I clinical trial to evaluate R7128 in combination with Pegasys (pegylated interferon) plus Copegus (ribavirin) in treatment-naive patients chronically infected with hepatitis C virus (HCV) genotype 1.
Dr Michelle Berrey, Pharmasset’s vice president, clinical development and chief medical officer, said: “The FDA’s fast track designation for R7128 acknowledges the urgent need for new HCV drugs. Currently, there are no HCV polymerase inhibitors approved for the treatment of chronic HCV infection.
“We continue to work closely with our HCV partner, Roche, and the FDA on the development and regulatory review of R7128, which has demonstrated compelling antiviral activity and has been generally well-tolerated in clinical trials to date.”