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Pegasys hepatitis C therapy gains U.S. approval

BASEL, SWITZERLAND, Oct 17, 2002 -- Roche announced that the FDA has approved Pegasys (peginterferon alfa-2a) for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not been previously treated with interferon alfa.

Patients in whom efficacy was demonstrated include patients with compensated cirrhosis.

The approval was based on the results of three pivotal Phase III clinical trials that demonstrated Pegasys's superior efficacy over conventional interferon, with sustained virological responses as high as 38% versus 19%, in patients with chronic hepatitis.

Pegasys is the only pegylated interferon indicated in the United States for treatment in patients with advanced liver disease, i.e. compensated cirrhosis.

In those patients who have a more treatment-resistant disease, Pegasys monotherapy achieves a sustained virological response (SVR) close to 4 times higher (30%) than conventional interferon therapy (8%).[1]

Higher SVR results were also found in patients with genotype 1, the most common type in the U.S. and the most difficult to treat. A SVR indicates that there is no detectable virus in the blood six months after completion of therapy.

"The United States represents a very important hepatitis C market. The approval of Pegasys means that Roche can now provide nearly 2.7 million Americans chronically infected with the hepatitis C virus with access to a new and significant treatment option," said William M. Burns, head of the pharmaceutical division at Roche. "Patients and physicians deserve to have choices and we feel confident that Pegasys will meet many of their needs."

One of the benefits of Pegasys is that it is the first pegylated interferon to have demonstrated that it is possible to determine after only three months whether a patient is likely or unlikely to respond successfully to therapy. Prior to Pegasys, patients had to wait twice as long to know if they were likely to achieve a sustained response to therapy with interferons.

Commenting on a Pegasys combination study recently published in the New England Journal of Medicine [2], lead author Dr. Michael Fried, Associate Professor of Medicine and Director of Clinical Hepatology at the University of North Carolina at Chapel Hill, noted: "Early prediction of virological response is a valuable tool for physicians. It can help identify who is likely to succeed with this treatment. Importantly, it can also help clinicians to determine whether to discontinue therapy for those not responding, saving patients the side effects and cost of additional therapy," he said. Dr. Fried cautioned that this must be considered on an individual patient basis.

Pegasys is currently under a priority review by the FDA for combination therapy with Roche's Copegus (ribavirin), and a decision is expected before the end of the year.

To date, more than 50 countries have approved Pegasys, and Copegus was recently approved by all European Union member states, paving the way for local country approvals during the next few months.

Pegasys, a new generation hepatitis C therapy that is different by design, provides significant benefit over conventional interferon therapy in patients infected with HCV of all genotypes. The benefits of Pegasys are derived from its new generation large 40 kilodalton branched-chain polyethylene glycol (PEG) construction, which allows for true seven-day viral suppression and preferential distribution to the liver, the primary site of infection.

Pegasys is the only pegylated interferon available as a ready-to-administer solution. Each weekly subcutaneous injection contains 180mcg of pegylated interferon alfa-2a which is the recommended dose for all patients, regardless of body weight. Patients are typically treated for 48-weeks.

[1] Heathcote, J.E. et al. Peginterferon alfa-2a in patients with chronic hepatitis C and cirrhosis. NEJM 2000;343:1673-1680

[2] Fried, Michael W et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection.NEJM 2002;347 (13): 975-982

Source: Roche

Posted: October 2002