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FDA Gives Hepatitis C Treatment ‘Fast Track’ Status

By Pharmaceutical Processing | February 11, 2011

Biopharmaceutical company Inhibitex Inc. said today the FDA 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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