Gilead Sciences – GILD – FDA Advisory Committee Supports Approval of Gilead’s Truvada®

Gilead Sciences, Inc. (Nasdaq:GILD) announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted to support approval of once-daily oral Truvada^® (emtricitabine and tenofovir disoproxil fumarate) to reduce the risk of HIV-1 infection among uninfected adults, an HIV prevention strategy called pre-exposure prophylaxis or PrEP. If the FDA decides to approve Truvada for PrEP, it would be the first agent indicated for uninfected individuals to reduce their risk of acquiring HIV.

In response to questions posed to the committee, members voted 19 to 3 in favor of approval for Truvada for PrEP in men who have sex with men; 19 to 2 (with 1 abstaining) in support of use in HIV-uninfected partners in serodiscordant couples; and 12 to 8 (with 2 abstaining) in other individuals at risk for acquiring HIV through sexual activity.

The recommendations of the Advisory Committee are not binding, but will be considered by the FDA as the agency completes its six-month priority review of Gilead’s supplemental New Drug Application (sNDA) of Truvada for PrEP. Gilead submitted the sNDA on December 15, 2011 and the FDA has established a target review date under the Prescription Drug User Fee Act (PDUFA) of June 15, 2012.

The committee’s positive recommendation followed presentations today of efficacy and safety data from several clinical studies of Truvada for PrEP, including two large placebo-controlled Phase 3 trials sponsored by the U.S. National Institutes of Health and the University of Washington, respectively. Several other clinical studies support the use of Truvada for HIV risk reduction.

Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and is currently the most-prescribed antiretroviral treatment in the United States. Truvada is not indicated for HIV prevention.

About Gilead Sciences – GILD

Gilead Sciences (GILD ) is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. GILD’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, GILD has operations in North America, Europe and Asia Pacific.

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Post Written By: Ed Liston Ed Liston is a senior contributing editor at TheStockMarketWatch.com. An active market watcher and investor, Ed guides an independent team of experienced analysts and writes for multiple stock trader publications. He is widely quoted in various financial publications on the Internet. When Ed is not writing about stocks, investing in stocks, talking about stocks, or otherwise doing something stock related, he likes to go sailing and fishing in his yacht.