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U.S. News

Gilead Submits Application to FDA Asking for PrEP Approval for Truvada

December 16, 2011

Pharmaceutical company Gilead Sciences on Thursday submitted an application to the FDA asking the agency to approve its antiretroviral drug Truvada for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection among adults, a Gilead press release reports. "If the [application] is approved, Truvada would be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV through sex," the press release notes (12/15).

Several international studies of the drug have shown it can reduce the risk of HIV infection among adults, according to the San Jose Mercury News. "It remains uncertain how the FDA will respond to the request, and reviews of drug applications can take years," the newspaper writes (Johnson, 12/15). The press release notes that "CDC is currently developing formal U.S. Public Health Service guidelines for the use of PrEP" (12/15).

Back to other news for December 2011


This information was reprinted from kff.org with permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the archives, and sign up for email delivery. © Henry J. Kaiser Family Foundation. All rights reserved.



  
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This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily Global Health Policy Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.
 
See Also
More on HIV Medications
More News on Truvada (Tenofovir/FTC)

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