Hepatitis C Therapy

U.S. FDA grants fast track designation to investigational oral HCV protease inhibitor

Published in Medical Letter on the CDC and FDA, March 5th, 2006

Schering-Plough reported that the U.S. Food and Drug Administration (FDA) has granted fast track designation to its investigational oral hepatitis C protease inhibitor (SCH 503034), currently in phase 2 clinical development for the treatment of chronic hepatitis C virus (HCV) infection.

The FDA granted Fast Track designation for the following reasons:

The proposed first indication for SCH 503034 is for treatment of HCV in patients with HCV genotype 1 virus who have not responded to combination therapy with pegylated interferon and ribavirin, the current standard of care.

SCH 503034 is an orally active inhibitor of the hepatitis C...

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Source: Medical Letter on the CDC and FDA (2006-03-05)

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