European Union Advisory Panel Expresses Support for Approval of Tenofovir
Two weeks after an FDA advisory panel recommended marketing approval for Gilead Sciences Inc.'s new anti-AIDS drug tenofovir, a similar panel in Europe has recommended to the European Union's Medicines Evaluation Agency that it should grant approval for European marketing of the drug, Reuters reports. When taken in conjunction with available antiretrovirals, tenofovir -- which will be sold under the brand name Viread -- has been shown to help patients who have developed resistance to already-available medications. Gilead officials said they anticipate that the FDA will make a final decision on the drug by Nov. 1, and final marketing authorization from the European Commission is expected early next year. "There are increasing needs across Europe for treatments to combat HIV infection," Dr. Brian Gazzard, clinical research director of Imperial College in London, said, "particularly for individuals who have failed other therapy" (Reuters, 10/18).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.