FDA fast track designation for CCR5 inhibitor vicriviroc (SCH-D)
14 July 2005. Related: Antiretrovirals.
The U.S. Food and Drug Administration (FDA) granted Fast Track designation to Schering-Ploughs CCR5 receptor antagonist vicriviroc (SCH-D, SCH-417690). 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.
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. Phase III clinical studies are expected to start this summer.
Source: Schering Plough Press Release