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FDA Panel Recommends Approval of New HIV DrugOctober 4, 2001 An advisory panel to the Food and Drug Administration yesterday supported approval of the new HIV drug Viread, made by Gilead Sciences Inc. The panel was split on whether to recommend the drug for all patients or only for those who have failed other courses of therapy. The drug targets reverse transcriptase, an enzyme essential to the replication of the virus and the spread of the disease in the body. Taken as a pill once a day, Viread has been shown to lower the quantity of HIV particles in the blood of 552 patients who have been "highly treated" with other antiretroviral medication for an average of 5.4 years. Only 3 percent of the patients who received Viread developed resistance to the drug after 24 weeks. The panel's opinion is not binding on the FDA, although the agency frequently follows the advice of its advisory panels. The drug was not approved for "front line" treatment because it has so far only been tested in patients that have received other HIV drugs. Wall Street Journal 10.04.01  This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update. |
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