European Union Grants Expanded Indication Approval to Gilead’s Viread
Foster City, Calif.-based Gilead Sciences yesterday announced that the European Union has approved its antiretroviral drug Viread for first-time therapy for HIV-positive individuals, Bloomberg/Los Angeles Times reports. The drug, which is Gilead's most promising product, received approval from European regulators last year for the treatment of HIV-positive patients who had already received other antiretroviral medications. The FDA approved Viread for use in the United States in 2001 (Bloomberg/Los Angeles Times, 5/28). The European Committee for Proprietary Medicinal Products and the Scientific Committee of the European Medicines Evaluation Agency approved the drug for use in all 15 E.U. member nations based on the results of a 49-week study of 600 HIV-positive patients who had never taken antiretroviral drugs before beginning the trial (Reuters, 5/27).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.