Summaries of health policy coverage from major news organizations
FDA Grants ‘Fast-Track’ Review Status to Roche’s Pegasys Hepatitis C Treatment
Roche AG said yesterday that the FDA has granted "fast-track" review status to the drug maker's hepatitis C treatment Pegasys, a new pegylated interferon, in combination with Copegus, its standard ribavirin therapy, the Wall Street Journal reports. Roche said it hopes to win FDA approval for the combination therapy in the fourth quarter and plans to launch the treatment in the United States next year. According to analysts, the decision "came as a relief" to Roche, which plans in the near future to launch only one other new drug "that should boost near-term growth," the AIDS drug T-20 (Wall Street Journal, 7/16). "The FDA's priority review designation for this application is an acknowledgement that Pegasys in combination with our Copegus provide new and important benefits to patients over the currently available treatments in the United States," William M. Burns, head of Roche's pharmaceuticals division, said (Roche release, 7/15). Pegasys was granted marketing approval for use alone or in conjunction with Copegus by the European Commission in June (Wall Street Journal, 7/16).
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