>>WASHINGTON -- Roche Holding AG announced Wednesday it won U.S. government approval of its long-acting, once-a-week hepatitis C treatment, Pegasys.
Pegasys will compete head-to-head with Schering-Plough Corp.'s Peg- Intron.
Roche, which has been waiting on this approval since it filed with the Food and Drug Administration in May 2000, plans to have the drug on pharmacy shelves within two weeks. The approval was held up, Roche said, because the FDA wanted additional information on a new plant Roche planned to use to produce the drug.
"We recognized the demand for Pegasys would exceed our forecast and took steps to increase the capacity," said Pamela Vanhouten, Roche's director of public affairs.
Like Schering-Plough's Peg-Intron, Pegasys is a long-acting form of interferon that makes it easier for patients to keep up with their doses. Before the long- acting forms won FDA approval, patients had to inject interferon three times per week.
Peg-Intron has a one year head start on Pegasys.
Both Pegasys and Peg-Intron are pegalated forms of interferon, meaning a molecule was added to the interferon to prevent the body from breaking it down quickly, thus cutting down on the number of doses needed.
Hepatitis C, an infection transmitted through blood, attacks the liver and is the leading cause for liver transplant. The infection can also lead to scarring of the organ and cancer.
About 3.9 million Americans are infected with hepatitis C according to the Centers for Disease Control and Prevention.
-Otesa Middleton, Dow Jones Newswires; 202-862-6654; Otesa.Middleton@ dowjones.com<<
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