Roche announced that the U.S. Food and Drug Administration (FDA) has approved Pegasys (peginterferon alfa-2a) for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated cirrhosis.

Pegasys is a pegylated interferon that remains active in the bloodstream longer and at a more constant level than interferon alpha. Currently, 2.7 million Americans are chronically infected with hepatitis C.

"The approval of Pegasys is an important milestone for the hepatitis C patients in the United States who are waiting for treatment," said George B. Abercrombie, President and Chief Executive Officer, Hoffmann-La Roche Inc. "Roche has supported Pegasys with the most extensive development program ever undertaken for a hepatitis C treatment. The result is that patients and physicians have an important new option for treatment."

Pegasys was granted approval based on the results of three pivotal Phase III clinical trials that demonstrated it is an effective treatment for patients with chronic hepatitis C, including cirrhotic patients with compensated liver disease, versus treatment with Roferon-A (interferon alfa-2a).

The sustained virological response rate in the Pegasys treated patients was as high as 38 percent in the overall population versus 19 percent in the interferon alfa-2a group. The sustained virological response in patients with cirrhosis treated with Pegasys was as high as 30 percent versus 8 percent in the interferon alfa-2a group. Higher sustained virological response results were also found in patients with genotype 1, on Pegasys treatment (23 percent) versus interferon alfa-2a (6 percent), the most common type in the U.S. and most difficult to treat. Sustained virological response was defined as undetectable serum hepatitis C RNA levels post-treatment (on or after study week 68).

Clinical trials of Pegasys have shown that patients can determine at 12 weeks if they are unlikely to attain a sustained virological response with Pegasys.

Pegasys is supported by the most extensive development program ever undertaken for a hepatitis C treatment. The FDA has granted Pegasys in combination with Copegus (Roche ribavirin) priority review status, and a decision is expected by the end of 2002. The FDA grants priority review status to products that, if approved, are expected to offer a significant improvement over existing therapies in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease.