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FDA advisory committee recommends approval of Gilead's Truvada for HIV prevention

Friday, May 11 2012 | Comments
Evidence Grade 0 What's This?
Gilead Sciences Inc.'s (emtricitabine/tenofovir disoproxil fumarate) should be approved to reduce the risk of HIV-1 among uninfected adults, according to a Food and Drug Administration advisory panel.

Gilead is proposing that Truvada be used in an HIV prevention strategy called pre-exposure prophylaxis (PrEP). If approved for PrEP, Truvada would be the first agent indicated for uninfected individuals to reduce their risk of acquiring HIV.

The FDA's Antiviral Drugs Advisory Committee voted 19-3 in favor of approving Truvada for PrEP in men who have sex with men; 19-2, with one abstention, in support of this use of the drug in HIV-uninfected partners in serodiscordant couples; and 12-8, with two abstentions, in other individuals who are at risk for acquiring HIV through sexual activity.

Gilead submitted the supplemental New Drug Application of Truvada in December, and the FDA granted it priority review status. The Prescription Drug User Fee Act action date is June 15.

Truvada is already indicated in combination with other antiretroviral agents for the treatment of HIV-1.

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