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FDA grants Fast Track designation to Schering-Plough's vicriviroc for HIV
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Schering Plough sent this announcement out.
The U.S. Food and Drug Administration (FDA) recently granted Fast Track designation to Schering-Plough's CCR5 receptor antagonist vicriviroc (SCH 417690) for the treatment of HIV infection. FDA Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
As you know, vicriviroc is currently being studied in two Phase II clinical trials, one in the United States and one in Europe and Canada. The U.S. Phase II trial, conducted by ACTG, is currently open for enrollment. The European trial is fully enrolled. We expect to begin Phase III clinical studies with vicriviroc this summer.
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