Antiviral Agent Copegus Tablet 200 mg Received Approval as a Combination Therapy with Chronic Hepatitis C Treatment Drug PegasysTOKYO, January 26, 2007 - Chugai Pharmaceutical Co., Ltd (Head office: Chuo-ku, Tokyo; President: Osamu Nagayama) (hereafter, "Chugai") announced that the antiviral ribavirin (trade name Copegus® tablet 200 mg, hereafter, "Copegus®") obtained an approval for combination therapy with the chronic hepatitis C treatment drug Pegasys®, trade names Pegasys® S.C. Injection 90 mcg and Pegasys® S.C. Injection 180 mcg (peginterferon alfa-2a, (genetic recombinant), hereafter, "Pegasys®"), on January 26, 2007.
Copegus® is an antiviral agent developed by F. Hoffmann-La Roche [Head Office: Basel, Switzerland. Chairman and CEO: Franz B.Humer] for use in combination with Pegasys® for treating chronic hepatitis C. After Copegus® was filed in the MHLW in June 2005; it was designated for priority review in September.
In the Japanese Phase III clinical study results of combination therapy of Pegasys® and Copegus® conducted in 300 patients with chronic hepatitis C, the sustained virological response (rate of HCV-RNA negative at week 24 after treatment period) was 59.4% in the combination group of Pegasys® and Copegus® (hereafter, "combination group") for interferon naive patients with genotype 1b high viral load (100 KIU/mL or higher HCV-RNA), and it showed a significantly higher virological response in comparison with that of 24.0% in the Pegasys® monotherapy group.
Furthermore, a 51.4% virological response was also observed in the combination group for interferon non-responders with genotype 1b high viral load who are considered to be the most difficult to treat.
The main adverse reactions that occurred by the time of approval in the combination group were 146 cases of fever (73.4%), 142 cases of injection site reaction (71.4%), and 138 cases of malaise (69.3%). Abnormal laboratory findings as adverse reactions included 184 cases of leukopenia (92.5%), 178 cases of neutropenia (89.4%), and 169 cases of decreased hemoglobin (84.9%).
Chugai believes that the introduction of the combination therapy
of Pegasys® and Copegus® leads to the advancement of
chronic hepatitis C treatment.
About the indications of Copegus®
Copegus® is used to improve either of the following viremia in chronic hepatitis C by combination therapy with peginterferon alfa-2a (genetic recombinant)
1. Patients in serogroup 1 (genotype I (1a) or II (1b)) with a high HCV-RNA load
2. Non-responders or relapsers by interferon monotherapy
Pegasys® is first pegylated interferon in Japan that enables chronic hepatitis C treatment by weekly administration and it has been reimbursed by health insurance since December 2003. It is currently used as a monotherapy for chronic hepatitis C.
As well as this approval for Copegus®, the additional indication of combination therapy for Pegasys® was also approved.
Pegasys® and Copegus® are registered trademarks of F. Hoffmann-La Roche & Co. Ltd (Switzerland).
Posted: January 2007