FDA gives Inhibitex treatment 'fast track' status
Feb 11, 2011
By The Associated Press
Biopharmaceutical company Inhibitex Inc. said Friday the Food and Drug Administration has designated its potential chronic hepatitis C treatment as a Fast Track development program.
The designation could help development and accelerate the review of new drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
The Alpharetta, Ga., company said the potential treatment, labeled INX-08189, is in an early-stage trial expected to be completed by the end of the first quarter. Inhibitex said characteristics of the drug that led to its Fast Track designation include a high genetic barrier to resistance and once-daily oral dosing.
Hepatitis C is a liver disease, and chronic cases of it are the leadng cause of liver transplants in the United States, according to Inhibitex.
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