Fast Track Granted to HCV Drug PSI-7977
Combining antiviral activity with a barrier to resistance, Pharmasset Inc.'s Hepatitis C drug, PSI-7977, has received fast track status by the FDA.
Pharmasset, Inc. (VRUS)'s PSI-7977 Receives Fast Track Designation from the FDA for the Treatment of Chronic Hepatitis C Infection
8/12/2010
PRINCETON, N.J., Aug. 12 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq:VRUS - News) has received fast track designation from the U.S. Food and Drug Administration (FDA) for PSI-7977 for the treatment of chronic hepatitis C virus (HCV) infection. PSI-7977 is an oral uridine nucleotide analog polymerase inhibitor of HCV. Pharmasset recently completed dosing in a 28 day Phase 2a trial to evaluate PSI-7977 in combination with Pegasys (pegylated interferon) plus Copegus (ribavirin) in treatment-naive patients chronically infected with HCV genotype 1. Pharmasset expects to initiate a 12-week Phase 2b study of PSI-7977 in the fourth quarter of 2010.
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