Pegasys approved for chronic hepatitis B in Switzerland

Roche today announced that Pegasys has been granted marketing authorisation by the Swiss regulatory authorities, Swissmedic, for the treatment of chronic hepatitis B.

The approval has been granted for both the HBe antigen-positive and HBe antigen-negative forms of the disease and was based on one of the largest ever clinical development programmes in hepatitis B, which included three global studies in more than 1,500 patients.

The studies proved Pegasys to be up to twice as effective as two first-line therapies currently recommended: interferon alfa and lamivudine. Pegasys, given once weekly as a 180µg subcutaneous injection over a 48-week period, works by a two-pronged approach, stimulating the immune system and inhibiting virus replication. This offers a new treatment option with the advantages of a finite treatment duration and lasting remission from the disease, according to Roche.

'This is a major milestone, not only for Switzerland, but for the more than 90 other countries worldwide that rely on Swiss regulatory review for their own approval process,' said William M. Burns, head of Roche's pharmaceutical division. 'Based on the results of our clinical programme, we would anticipate that Pegasys will become a first-line treatment for chronic hepatitis B.'