FDA Panel Voices Support For Gilead’s Antiretroviral Viread
An FDA advisory panel in an informal vote yesterday endorsed Gilead Sciences Inc.'s new HIV treatment tenofovir, the San Francisco Chronicle reports (Abate, San Francisco Chronicle, 10/4). The panel unanimously voted to support use of tenofovir in patients who have already tried other antiretroviral medications, but was split on whether to recommend the drug for those who were just beginning treatment, with nine members voting against use of the drug in treatment naive patients and seven voting in favor (Reuters/New York Times, 10/4). Tenofovir, the only HIV antiretroviral currently under consideration by the FDA for marketing approval, works by blocking an enzyme needed in the HIV replication process. The company tested tenofovir on HIV-positive patients who had been taking other antiretrovirals for at least five years, most of whom had developed drug resistance and had experienced an increase in viral load. Trial results showed that when paired with other antiretroviral drugs, tenofovir reduced viral load by 75% (Kaiser Daily HIV/AIDS Report, 10/3). The FDA will take the panel's recommendation into consideration later this month when the agency takes a final vote on marketing approval for the drug. Approval for use in patients with drug resistance is expected and Gilead plans to have tenofovir, marketed under the name Viread, in pharmacies in early November. The company is seeking expanded approval and is conducting additional trials to determine the drug's effectiveness in treatment naive individuals. Tom Dietz, an analyst for Pacific Growth Equities, said, "It's typical that you ask for the moon even if you know you can't get it. What [the endorsement] means is that they'll get the drug on the market, and they'll expand the use of it once it's there." He added that Gilead can expect up to $250 million in annual sales even with limited approval (San Francisco Chronicle, 10/4).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.