The combination of Pegasys (peginterferon alfa-2a (40KD)) plus Copegus (ribavirin) has been awarded priority review status by the Japanese Regulatory Agency (MHLW). This brings forward the review time by approximately 6 months, with approval of the combination expected in Q3, 2006, Roche and Chugai announced here.

The filing was based on results from a landmark phase III Japanese clinical trial showing that 61% of treatment naïve genotype 1b patients who received Pegasys plus Copegus achieved a sustained virological response (which is indicative of a cure) compared with 26% of patients who received Pegasys alone. This is a breakthrough for combination treatment, providing the highest sustained virological response (SVR) rates reported in these patients. Patients with genotype 1b hepatitis C are considered to be a difficult group of patients treat.

“The priority review granted for Pegasys plus Copegus demonstrates both the need for better treatment options for Japanese patients with hepatitis C, and the significance of the clinical trial results,” said Ed Holdener, Head Global Pharmaceutical Drug Development at Roche.

This is the largest phase III clinical trial to examine the efficacy and safety profile of the combination of Pegasys plus ribavirin in Japanese patients. The trial was conducted in 43 centres in Japan and enrolled 300 patients.

Pegasys is marketed in Japan by Chugai Pharmaceutical Co. Ltd. In Japan, Pegasys was approved in October 2003 with the indication for monotherapy treatment of chronic hepatitis C and is marketed under the tradename of Pegasys. Ribavirin is currently being developed in Japan by Chugai Pharmaceutical Co Ltd. Outside Japan, this drug is used as an anti-virus therapy for treatment of various types of infectious diseases. The ribavirin used in this trial is a ribavirin tablet (overseas trade name: Copegus) developed by Roche for use in combination with Pegasys for the treatment of chronic hepatitis C.