The EU Commission has approved Roche's Pegasys (peginterferon alfa-2a (40KD)) for the treatment of chronic hepatitis B. The approval is granted for both types of the disease - HBeAg-positive and HBeAg-negative chronic hepatitis B.
"Pegasys is well-known to physicians as a highly effective treatment for chronic hepatitis C and we are glad the EU Commission has recognised the benefits it also offers to patients with chronic hepatitis B," said William M. Burns, CEO of Roche's Pharmaceutical Division. "Pegasys is the only pegylated interferon with this indication and the approval means that physicians now have a medication that can be taken for a defined period of time and offers long-term remission after stopping treatment," he asserted.
In the Mediterranean countries and Eastern Europe the HBeAg-negative form of chronic hepatitis B, which is more difficult-to-treat and associated with a poorer prognosis, is particularly prevalent.
"Pegasys achieves sustained remission in a significant number of patients with chronic hepatitis B following a defined 48-week treatment period," Professor Patrick Marcellin, one of the lead investigators of the Phase III global studies said adding, "In clinical trials, Pegasys has demonstrated its effectiveness against both forms of the disease, and has demonstrated superior benefits against the two leading medications used to treat it today, lamivudine and conventional interferon. These results support its use as first line therapy for chronic hepatitis B."
Pegasys works with a dual mode of action: it stimulates the immune system as well as inhibits virus replication. This offers physicians a new option with the advantages of finite treatment duration and lasting remission from the disease, avoiding the burden of putting their patients on a life-long therapy, the release stated.
Pegasys has recently been approved for the treatment of chronic hepatitis B in the European Union, Hong-Kong, India, New Zealand, Switzerland, Taiwan and Thailand. Approval in the US is expected this year.