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.