Schering’s HCV combo gains indication
Executive Summary
FDA approves new labeling for Schering-Plough's PegIntron (peginterferon alfa-2b) and Rebetol (ribavirin) combination therapy for treating chronic hepatitis C in patients with compensated liver disease, making it the first HCV combination approved in the U.S. that is not restricted to treatment-naïve patients. The label expansion, approved days after the announcement that Schering will merge with Merck, comes as the firm is moving ahead with Phase III trials of its direct antiviral for HCV, the protease inhibitor boceprevir