Roche files for application with FDA to market hepatitis C medication Pegasys(R) for chronic hepatitis B treatment

Jul 21 2004

Roche announced today the submission of a supplemental new biologics license application (sBLA) with the U.S. Food and Drug Administration to market Pegasys(R) (peginterferon alfa-2a) for the treatment of chronic hepatitis B (CHB).

Simultaneously, Roche has also filed with the European Medicines Agency to market Pegasys for this indication in the European Union. Pegasys received FDA approval for the treatment of chronic hepatitis C in October 2002 and today is the most prescribed chronic hepatitis C medication in the U.S.

"Hepatitis B is a serious public health threat worldwide and can be deadly if left untreated," said Salvatore Badalamente, M.D., Medical Director, Roche. "We are committed to offering Pegasys as a new option to the millions of people throughout the world who are chronically infected with hepatitis B."

Roche submitted this filing based on Pegasys data from its comprehensive clinical development program in hepatitis B. This program involved more than 1,500 chronic hepatitis B patients from three separate studies. A phase II study compared Pegasys to standard interferon in patients with HBeAg-positive disease. Two phase III studies compared Pegasys to Epivir-HBV(R) (lamivudine) in patients with HBeAg-positive disease and in patients with HBeAg-negative disease (a more difficult to treat mutation of the hepatitis B virus), respectively. The two studies are the largest trials conducted to date in the patient populations infected with either variation of hepatitis B.

"Each year an estimated 5,000 to 6,000 people die in the United States because of chronic hepatitis B liver disease. We recognize the need for new hepatitis B treatment options and commend Roche for its extensive research to advance hepatitis B therapy," said Alan Brownstein, President and Chief Executive Officer, American Liver Foundation.