Schering hepatitis drug gets fast track status

The drug, named SCH 503034, is an orally active inhibitor of the hepatitis C virus (HCV) 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. The treatment is currently in phase II clinical development.

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 company to improve the efficiency of product development.

SCH 503034 has demonstrated potent antiviral activity and was well- tolerated, both as monotherapy and in combination with another of the company’s products Peg-intron (peginterferon alfa-2b). In phase I clinical studies patients chronically infected with HCV genotype 1 who had not responded to previous therapy seemed to benefit from SCH 503034.

Based on the results of the phase I clinical program and extensive preclinical safety and pharmacology studies, Schering-Plough is conducting a large, randomized phase II dose-finding study involving 300 patients worldwide. This study is further evaluating the safety and efficacy of SCH 503034 in combination with Peg-intron.