Advertisement
The Body: The Complete HIV/AIDS Resource
Follow Us Follow Us on Facebook Follow Us on Twitter Download Our App
Professionals >> Visit The Body PROThe Body en Espanol
  
  • Email Email
  • Comments Comments
  • Printable Single-Page Print-Friendly
  • Glossary Glossary

Press Release

U.S. FDA Grants Priority Review for Truvada for Reducing the Risk of Acquiring HIV Infection

February 13, 2012

Foster City, Calif. (Business Wire) -- Gilead Sciences, Inc. (Nasdaq:GILD) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) and granted a six-month Priority Review for once-daily Truvada® (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection among uninfected adults. Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and is currently the most-prescribed antiretroviral treatment in the United States.

The FDA grants priority review status to drug candidates that provide major advances in treatment or provide a treatment where no adequate therapy exists. Gilead submitted the Truvada for PrEP sNDA on December 15, 2011. The FDA has set a target review date for Truvada for PrEP under the Prescription Drug User Fee Act (PDUFA) of June 15, 2012. The agency has also indicated that Truvada for PrEP will be discussed at the FDA Antiviral Drugs Advisory Committee meeting scheduled in May.

If the sNDA is approved, Truvada would be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV. The sNDA is based on the results of two large placebo-controlled trials of Truvada as PrEP sponsored by the U.S. National Institutes of Health and the University of Washington. Several other clinical studies support the use of Truvada for HIV risk reduction.

Truvada is not currently indicated to reduce the risk of HIV infection.



  
  • Email Email
  • Comments Comments
  • Printable Single-Page Print-Friendly
  • Glossary Glossary

This article was provided by Gilead Sciences, Inc..
 
See Also
More News and Research on HIV Medications for HIV Prevention
Advertisement:
Find out how a Walgreens specially trained pharmacist can help you

No comments have been made.
 

Add Your Comment:
(Please note: Your name and comment will be public, and may even show up in
Internet search results. Be careful when providing personal information! Before
adding your comment, please read TheBody.com's Comment Policy.)

Your Name:


Your Location:

(ex: San Francisco, CA)

Your Comment:

Characters remaining:

Tools
 

Advertisement