PRINCETON, N.J. An investigational drug made by Pharmasset for treating hepatitis C will get expedited review from the Food and Drug Administration.
The FDA gave fast-track designation to PSI-7977. The designation is meant to facilitate development and expedite review of a drug intended to treat a serious or life-threatening condition and demonstrates potential to address unmet medical needs.
Pharmasset recently completed dosing in a mid-stage clinical trial of the drug that combines it with Genentech’s Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) in chronically infected patients who have not received treatment. Following the current phase 2a trial, Pharmasset will start a 12-week phase 2b trial in fourth quarter 2010.