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... Schering-Plough Reports FDA Grants Fast Track Designation to Oral HCV Protease Inhibitor SCH 503034 Schering-Plough Reports FDA Grants Fast Track Designation to Oral HCV Protease Inhibitor SCH 503034 KENILWORTH, N.J., Jan.

30 /PRNewswire-FirstCall/ - Schering-Plough today 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 II 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, thus representing an unmet medical need.

SCH 503034 is an orally active inhibitor of the hepatitis C virus serine protease that inhibits HCV replication.

This mechanism is distinct from those of current therapies, thus SCH 503034 represents a novel class of HCV inhibitor.

Fast Track designation allows FDA to expedite review of drugs and biologics for serious or life-threatening conditions and which demonstrate the potential to address unmet medical needs.

An important feature of Fast Track designation is that it emphasizes the critical nature of close, early communication between the FDA and the sponsor compa...

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