Schering Hepatitis Drug Gets Fast Track Status
Posted on: Wednesday, 1 February 2006, 15:00 CST
The FDA has agreed to review Schering-Plough's investigational oral hepatitis C drug on a fast track basis, potentially allowing the treatment to reach the market quicker.
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.
Source: Datamonitor
Related Articles
- GlobeImmune HCV Phase 2 Four-Week Clinical Trial Data for GI-5005 to Be Highlighted at the AASLD President's Press Conference
- Cerimon Pharmaceuticals Initiates Phase II/III Clinical Studies to Evaluate Its Diclofenac Patch for Mild to Moderate Pain
- Merck Initiates Phase II/III Clinical Trial of SLE
- Biothera Initiates Phase Ib/IIa Clinical Trial With Imprime PGG and Erbitux in Metastatic Colorectal Cancer Patients
- ISTA Pharmaceuticals Announces Statistically Significant Preliminary Results From Its U.S. Phase II/III Clinical Study Of Bepotastine
- Nutra Pharma Announces Final Approval to Begin Phase IIb Human Clinical Trial for the Treatment of Adrenomyeloneuropathy
- Corautus Responds to FDA Clinical Hold on Angina Trial
- Schering-Plough Reports FDA Grants Fast Track Designation to Oral HCV Protease Inhibitor SCH 503034
- InterMune Enrolls 600th Patient in Phase III INSPIRE Clinical Trial
- Dendreon Completes Enrollment in Phase 3 PROTECT (P-11) Clinical Trial of Provenge in Early Stage Prostate Cancer
 |
 |
User Comments (0)
RSS Feeds