February 13, 2012
U.S. FDA Grants Priority Review for Truvada® for Reducing the Risk of Acquiring HIV Infection
FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 13, 2012--
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
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.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Miller, 650-522-1616 (Media)