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Roche Pegasys/Copegus combo approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA clears Roche's Pegasys (peginterferon alfa-2a) Dec. 3 for combination use with Copegus (ribavirin) for treatment of adults with chronic hepatitis C and compensated liver disease who have not previously received interferon alfa. Dosing is based on viral genotype; the recommended dose is 180 mcg Pegasys plus 1,000-1,200 mg Copegus for 48 weeks for patients with HCV genotype 1 or 4, and 180 mcg Pegasys plus 800 mg Copegus for 24 weeks for genotype 2 or 3 patients. Labeling reports a 53% sustained virological response for Pegasys/Copegus compared to 44% for Schering-Plough's Rebetron (interferon alfa-2b/ribavirin) (Pharmaceutical Approvals Monthly, June 2002, p. 3). Pegasys monotherapy was approved Oct. 16. Roche says the combination therapy will launch in early 2003 when Copegus will be available in pharmacies; Copegus and Pegasys will be sold separatel

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