U.S. FDA Grants Priority Review for Truvada® for Reducing the Risk of Acquiring HIV Infection
February 13 2012 - 7:25PM
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.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers,
develops and commercializes innovative therapeutics in areas of
unmet medical need. The company’s mission is to advance the care of
patients suffering from life-threatening diseases worldwide.
Headquartered in Foster City, California, Gilead has operations in
North America, Europe and Asia Pacific.
Forward-Looking
Statement
This press release includes forward-looking statements, within
the meaning of the Private Securities Litigation Reform Act of
1995, that are subject to risks, uncertainties and other factors,
including the risk that the FDA may not approve Truvada for HIV-1
risk reduction, and any approval, if granted, may have significant
limitations on its use. Additionally, even if approved, physicians
may be reluctant to prescribe the product for HIV risk reduction,
and payers may be reluctant to approve or provide reimbursement for
the product for HIV risk reduction. As a result, there may not be
significant use of Truvada as a risk reduction tool. These risks,
uncertainties and other factors could cause actual results to
differ materially from those referred to in the forward-looking
statements. The reader is cautioned not to rely on these
forward-looking statements. These and other risks are described in
detail in Gilead’s Quarterly Report on Form 10-Q for the quarter
ended September 30, 2011, as filed with the U.S. Securities and
Exchange Commission. All forward-looking statements are based on
information currently available to Gilead, and Gilead assumes no
obligation to update any such forward-looking statements.
U.S. full prescribing information for Truvada
is available at www.Truvada.com.
Truvada is a registered trademark of Gilead
Sciences, Inc.
For more information on Gilead Sciences, please
visit the company’s website at www.gilead.com or call Gilead Public
Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Sep 2024 to Oct 2024
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Oct 2023 to Oct 2024