U.S. FDA Accepts New Drug Application for Gilead’s Once-Daily, Single-Tablet Quad HIV Regimen
December 23 2011 - 5:15PM
Business Wire
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the
U.S. Food and Drug Administration (FDA) has accepted for review the
New Drug Application (NDA) for the Quad, a complete single-tablet
HIV regimen containing elvitegravir, cobicistat, emtricitabine and
tenofovir disoproxil fumarate.
Gilead submitted the Quad NDA on October 27, 2011. The FDA has
set a target review date for the Quad under the Prescription Drug
User Fee Act (PDUFA) of August 27, 2012.
About the Quad
The Quad contains four Gilead compounds in a complete
once-daily, single-tablet regimen: elvitegravir; cobicistat, a
“boosting” agent that enables elvitegravir once-daily dosing; and
Truvada® (emtricitabine/tenofovir disoproxil fumarate).
About Elvitegravir
Elvitegravir is an integrase inhibitor. Unlike other classes of
antiretroviral agents, integrase inhibitors interfere with HIV
replication by blocking the ability of the virus to integrate into
the genetic material of human cells. Elvitegravir was licensed by
Gilead from Japan Tobacco Inc. (JT) in March 2005. Under the terms
of Gilead’s agreement with JT, Gilead has exclusive rights to
develop and commercialize elvitegravir in all countries of the
world, excluding Japan, where JT retains rights.
About Cobicistat
Cobicistat is Gilead's proprietary potent mechanism-based
inhibitor of cytochrome P450 3A (CYP3A), an enzyme that metabolizes
drugs in the body. In addition to studying the agent as part of the
Quad, Gilead is also examining cobicistat's potential in boosting
commercially available HIV protease inhibitors, which are used in
many HIV treatment regimens.
The Quad, elvitegravir and cobicistat are investigational
products and their safety and efficacy have not yet been
established.
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 the Quad in the
anticipated timelines or at all, and that any marketing approval,
if granted, may have significant limitations on its use. Further,
even if approved, Gilead may not be able to successfully
commercialize the Quad and may make a strategic decision to
discontinue development of the Quad 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, 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 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.
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