PEGASYS + RIBAVIRIN AWARDED PRIORITY REVIEW STATUS BY JAPANESE REGULATORY AGENCY

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.

Pharmabiz (http://www.pharmabiz.com/article/detnews.asp?articleid=29371)