Gilead Sciences Refiles New Drug Application with the FDA for Single-Tablet Regimen of Truvada® and TMC278
February 10 2011 - 4:05PM
Business Wire
Gilead Sciences, Inc. (Nasdaq:GILD) announced today that it has
refiled a New Drug Application (NDA) with the U.S. Food and Drug
Administration (FDA) for the single-tablet regimen of Truvada®
(emtricitabine and tenofovir disoproxil fumarate) and Tibotec
Pharmaceuticals’ investigational non-nucleoside reverse
transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for
HIV-1 infection in adults.
Gilead previously submitted an NDA for the single-tablet regimen
of Truvada/TMC278 on November 23, 2010. The company announced on
January 25, 2011 that it had received a “refuse to file”
notification from the FDA regarding that submission. Specifically,
the FDA requested additional information on the analytical
methodology and qualification data used to establish acceptable
levels of recently identified degradants related to emtricitabine;
this information has been included in the refiling.
The FDA has up to 60 days to conduct a preliminary review to
assess whether the NDA is sufficiently complete to permit a
substantive review. The FDA will establish a target action date for
the NDA, under the Prescription Drug User Fee Act (PDUFA), if the
application is formally filed.
About Gilead
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 Australia.
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 risks related to the fact that the FDA may not be
satisfied with the additional informational submitted by Gilead and
may not approve Truvada/TMC278 for the treatment of HIV-1 infection
in adults. In addition, any marketing approval, if granted, may
have significant limitations on its use. Further, Gilead and
Tibotec may make a strategic decision to discontinue development or
commercialization of Truvada/TMC278 if, for example, the market for
the product fails to materialize as expected. 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, 2010, 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.
For more information on Gilead Sciences, please
visit www.gilead.com orcall the Gilead Public Affairs Department at
1-800-GILEAD-5 (1-800-445-3235).
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