Fuzeon Receives Expedited FDA Review Status
Swiss drug maker Roche and its U.S. partner Trimeris Inc. said on Friday that the FDA has given their new fusion inhibitor Fuzeon priority review status, the AP/Las Vegas Sun reports (AP/Las Vegas Sun, 10/11). Fuzeon, formerly known as T-20, is the first in a new class of antiretroviral drugs called fusion inhibitors, which are designed to prevent HIV from entering cells. The drug was developed for patients who have drug-resistant strains of the virus and is intended to be administered in combination with other antiretroviral drugs (Kaiser Daily HIV/AIDS Report, 9/30). The FDA will review the drug by March 16, 2003, six months after its makers requested the expedited review (Ranii, Raleigh News & Observer, 10/12). Approval could have taken up to 12 months without the priority review. AIDS advocates are optimistic about Fuzeon but fear that it will be too expensive for use by many patients. Roche and Trimeris will not discuss price, but observers have predicted the drug will cost between $10,000 and $15,000 per year (AP/Las Vegas Sun, 10/11).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.