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Next issue for Gilead's Truvada to prevent HIV: What REMS will FDA require
Monday, May 14, 2012
Last week's positive FDA panel vote sets the stage for
approval of the first drug to prevent HIV infection. The onus will now be on
the agency and Gilead
Sciences Inc. to design and implement a postmarketing education and
surveillance program for use of Truvada emtricitabine/tenofovir that will
provide high-risk individuals with access to the drug without encouraging risky
The Antiviral Drugs Advisory
Committee voted 19-3 in favor of approval of the Truvada for high-risk men who
have sex with men. It voted 19-2, with one abstention, in favor of approval in
serodiscordant heterosexual couples.
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