Chugai submits application for additional indication of Pegasys, Copegus
PBR Staff Writer
Published 27 October 2010
Chugai Pharmaceutical has submitted an application to the Ministry of Health, Labour and Welfare for the approval of an additional indication, 'improvement of viraemia associated with compensated cirrhosis related to hepatitis C' for the combination therapy of Pegasys and Copegus.
Pegasys, under the trade names Pegasys SC 90mg and Pegasys SC 180mg (peginterferon alfa-2a) (hereafter Pegasys) and Copegus, under the trade name Copegus 200mg tablets (ribavirin) are currently marketed for the indication of improvement of viraemia associated with chronic hepatitis C (CHC).
Chugai said that the application was based on the domestic Phase II/III clinical study, which was conducted as a partial-blind comparative study, which randomised patients with compensated cirrhosis related to hepatitis C to two parallel groups, combination therapy of Pegasys and Copegus vs treatment-free group, in order to compare the efficacy and safety of the combination therapy of Pegasys and Copegus against the treatment-free group.
Chugai will make efforts for the early approval of the combination therapy of Pegasys and Copegus for improvement of viraemia in CHC patients with compensated cirrhosis so that the therapy becomes available for the patients as early as possible.
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