May 9, 2012
FDA Staff Supports Truvada PrEP in Advance of Hearing
Staff from the Food and Drug Administration (FDA) have found
Truvada, a pill from Gilead Sciences, to be safe and effective when used to
protect HIV-negative people from getting the virus, Bloomberg Businessweek
reports. Gilead would be the first company to sell a drug for pre-exposure
prophylaxis (PrEP) treatment. FDA staff found Truvada to be “well-tolerated,”
and they accepted data from two studies that supported its ability to reduce
the risk of infection. Regulators have said that their main concerns are when
and how it should be used, what tests should be required for patients and what
information should be used for patients and doctors. FDA advisers will hold a
hearing May 10 to consider approving Truvada as PrEP.
To read the Bloomberg Businessweek article, click here.
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