The first drug shown to prevent HIV infection has been recommended for approval by a US Food and Drug Administration (FDA) panel.
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The Antiviral Drugs Advisory Committee has voted to support Gilead Sciences’ once-daily oral Truvada drug to reduce the risk of infection in uninfected adults.
The recommendation follows presentations of efficacy and safety data from several clinical studies, including placebo-controlled phase 3 trials.
Members of the panel voted 19 to three in favour of approval for Truvada in men who have sex with men; 19 to two (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 of Truvada for the prevention of HIV.
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By GlobalDataThe FDA has established a target review date, under the Prescription Drug User Fee Act, of 15 June 2012.
Truvada was approved by the FDA in 2004 for the treatment of the HIV-1 infection and is currently the most-prescribed antiretroviral treatment in the US.
Image: As yet, no drug has been approved for the prevention of HIV. Image courtesy of: C. Goldsmith.
