FDA Approves Roche’s Pegasys-Copegus Hepatitis C Combination Treatment
The FDA on Tuesday approved Roche's Pegasys hepatitis C drug for use in combination with the antiviral drug ribavirin, Reuters/Houston Chronicle reports (Reuters/Houston Chronicle, 12/3). In October, the FDA approved the use of Pegasys, an improved interferon, by itself as a treatment for HCV. The combination regimen of interferon-alpha and ribavirin has been the traditional hepatitis C treatment for several years, but interferon-alpha must be injected three times per week. Pegasys, a long-lasting form of interferon, must be injected only once a week. Recent studies have shown that a combination regimen of ribavirin and Pegasys is more effective at lowering hepatitis C viral levels than treatment with ribavirin and interferon-alpha (Kaiser Daily HIV/AIDS Report, 10/17). The FDA's approval of Roche's Pegasys-Copegus combination treatment could put the company in position to challenge Schering-Plough's current "dominance" of the $1 billion market for hepatitis C treatments (Kaiser Daily HIV/AIDS Report, 11/19). Roche is also testing Pegasys to treat hepatitis B, Reuters/Houston Chronicle reports (Reuters/Houston Chronicle, 12/3).
In related news, Roche on Tuesday said there have been no "problems producing" its experimental antiretroviral Fuzeon, despite such "speculation," Reuters reports (Reuters, 12/3). Fuzeon, co-developed with Durham, N.C.-based Trimeris, is one of a new class of fusion inhibitors, designed to be used in combination with other antiretroviral therapies and "is eagerly awaited" by HIV-positive people who have developed resistance to other antiretroviral drugs (Kaiser Daily HIV/AIDS Report, 11/19). The drug is "difficult to make" and the company said earlier this year that it would have to "ration supplies initially," according to Reuters. A Roche spokesperson said, "There is no new guidance. There is nothing to correct here. There is no new information. It is just speculation." He added, "We are waiting for new batches (of Fuzeon) to be evaluated so we can give clearer guidance for 2003, but this is still to come. We expect this either somewhat later this month or early January and this will allow us to calculate how many patients can be provided with the drug" (Reuters, 12/3). The FDA is currently reviewing Fuzeon, and the agency is scheduled to review the drug by March 16, 2003 (Kaiser Daily HIV/AIDS Report, 11/19).