Pegasys approved in Japan for the treatment of hepatitis C

Chugai Pharmaceutical, a member of the Roche Group, has received approval to market Pegasys (peginterferon α-2a) in Japan for the treatment of chronic hepatitis C.

It is the first pegylated interferon to be approved in Japan, the world's second largest hepatitis C market. Patients will require a single weekly injection of 180mcg of Pegasys compared with the current practice of two initial weeks of daily injections of conventional interferon, followed by injections three times weekly.

'There are approximately 1.5 million people in Japan who have chronic hepatitis C and until today, the available medications have been either conventional interferon alone or combined with ribavirin,' said William M Burns, head of Roche's Pharmaceutical Division. 'We believe the Japanese health authorities recognise that there are significant benefits from Pegasys therapy, as it was designated 'fast track' approval and this has occurred in under a year.'

Pegasys has been introduced in more than 80 countries including Europe, North and South America and the Asia-Pacific region. Three global trials were conducted with monotherapy from 1997 to 1999 while two pivotal trials with combination therapy with Copegus (Roche ribavirin) were conducted between 1998 and 2002. In monotherapy, Pegasys has achieved an overall 39% sustained virological response compared with a 19% response with conventional interferon.