Roche announced that Pegasys (peginterferon alfa-2a (40KD)) has been granted marketing authorization 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 clinical development programmes in hepatitis B ever, which included three global studies in more than 1,500 patients.
The studies showed that Pegasys was superior to two therapies currently recommended first-line; interferon alfa and lamivudine. In contrast to lamivudine, the most commonly prescribed medication today, Pegasys works by a two-pronged approach. It stimulates the immune system as well as inhibits virus replication. This offers physicians a new option with the advantages of a finite treatment duration and lasting remission from the disease.
"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," he said, adding that Pegasys is the worldwide market leader for the treatment of hepatitis C.
Chronic hepatitis B is a major global healthcare problem affecting more than 350 million people and it is one of the principal causes of liver failure, cirrhosis, and liver cancer. Between one-quarter and one-third of people with chronic hepatitis B will go on to develop progressive liver disease; and approximately one million die annually, making it the 10th leading cause of death worldwide.
Pegasys has been proven twice as effective as conventional interferon for the treatment of the most common form of chronic hepatitis B, hepatitis B e antigen (HBeAg) -positive chronic hepatitis B, in a multinational phase II trial. These findings were published in the July 2003 Journal of Viral Hepatitis.
Two large-scale multinational phase III trials, in patients with both the HBeAg-positive and HBeAg-negative forms of chronic hepatitis B, demonstrated that after 48 weeks of therapy, more patients achieved a sustained response with Pegasys than with lamivudine. Furthermore, these studies demonstrated that the addition of lamivudine to Pegasys did not improve response rates over Pegasys alone.
The phase III study results in HBeAg-negative chronic hepatitis B, the most difficult-to-treat form of the disease, were published in September in the New England Journal of Medicine2, and the results of the phase III study in patients with HBeAg-positive chronic hepatitis B were presented at the 2004 Annual Meeting of the American Association for the Study of Liver Diseases in November3. Both lead investigators have stated that the results of these trials warrant Pegasys becoming the first-line treatment for HBeAg-positive or HBeAg-negative chronic hepatitis B.
"Until now, conventional interferon or lamivudine have been the first-line treatments for patients with chronic hepatitis B, but these clinical trials have proven that Pegasys outperforms both," said Dr George Lau, gastroenterologist at the Queen Mary Hospital, Hong Kong; and Assistant Dean in the Department of Medicine at the University of Hong Kong. "This approval means that we have a significant new option whereby patients can achieve a lasting remission and we only need to provide treatment for a limited 48-week period."
Pegasys was filed for the treatment of chronic hepatitis B simultaneously in Switzerland, the United States and the European Union in the summer of 2004, and approvals in the US and the EU are anticipated early in 2005. It is the first pegylated interferon indicated for the treatment of chronic hepatitis B anywhere in the world and has already been approved for this indication in Thailand and Taiwan.
Pegasys, a new generation hepatitis therapy that is different by design, has already become the worldwide market leader in hepatitis C. Pegasys has a dual immunomodulatory and antiviral mode of action. The improved pharmacokinetic profile ensures drug plasma concentrations are maintained at constant levels throughout the one week dosing interval.