Gilead Submits New Drug Application to U.S. Food & Drug Administration for Fixed-Dose Combination of Emtricitabine/Tenofovir ...
April 07 2015 - 5:56PM
Business Wire
–Potential New Backbone for Future HIV
Therapy Combinations–
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that it has
submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for two doses of an investigational fixed-dose
combination of emtricitabine and tenofovir alafenamide (200/10 mg
and 200/25 mg) (F/TAF) for the treatment of HIV-1 infection in
adults and pediatric patients age 12 years and older, in
combination with other HIV antiretroviral agents.
TAF is a novel nucleotide reverse transcriptase inhibitor (NRTI)
that has demonstrated high antiviral efficacy at a dose less than
one-tenth that of Gilead’s Viread® (tenofovir disoproxil
fumarate, TDF), as well as improved renal and bone laboratory
parameters as compared to TDF in clinical trials.
“Gilead has a long history of innovating HIV treatments, and
with F/TAF we have the potential to further optimize therapies for
HIV patients who face a lifetime of antiretroviral treatment,” said
Norbert Bischofberger, PhD, Executive Vice President, Research and
Development and Chief Scientific Officer, Gilead Sciences. “With
its high antiviral efficacy and favorable safety profile, F/TAF may
offer an improved backbone for a new generation of HIV
regimens.”
Today’s filing is Gilead’s second F/TAF-based NDA submitted to
the FDA for review. In November 2014, Gilead filed an NDA for an
investigational once-daily single tablet regimen containing
elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and
TAF 10 mg (E/C/F/TAF). Under the Prescription Drug User Fee Act,
the FDA has set a target action date of November 5, 2015.
Additionally, a Marketing Authorization Application in the European
Union for E/C/F/TAF was fully validated on December 23, 2014.
The F/TAF NDA is supported by data from Phase 3 clinical studies
evaluating the safety and efficacy of E/C/F/TAF for the treatment
of HIV-1 infection among treatment-naïve adults, in which the
F/TAF-based regimen (administered as E/C/F/TAF) resulted in
non-inferior efficacy and improved renal and bone laboratory
parameters as compared to F/TDF-based therapy (administered as
E/C/F/TDF or Stribild®). The NDA is also supported by data from
additional Phase 3 studies evaluating the F/TAF-based regimen
(administered as E/C/F/TAF) among treatment-naïve adolescents,
virologically suppressed adults who switched regimens and adults
with mild-to-moderate renal impairment. Lastly, bioequivalence
studies demonstrated that the formulation of the fixed-dose
combinations of F/TAF achieved the same drug levels in the blood as
in E/C/F/TAF.
The recommended dose of F/TAF is 200/25 mg; if it is used in
combination with a protease inhibitor that is administered with
either ritonavir or cobicistat, the recommended dose is 200/10
mg.
Additional F/TAF-based regimens for HIV treatment are currently
in development. In December 2014, Gilead announced the expansion of
its existing agreements with Janssen Sciences Ireland UC for the
development and commercialization of two new investigational
once-daily single tablet regimens containing F/TAF. One combines
F/TAF with Janssen’s rilpivirine. The other regimen contains F/TAF,
cobicistat and Janssen’s darunavir.
Gilead plans to submit a regulatory application for F/TAF in the
European Union in the second quarter of 2015.
F/TAF-based regimens are investigational products and have not
been determined to be safe or efficacious.
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. Gilead has
operations in more than 30 countries worldwide, with headquarters
in Foster City, California.
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 possibility that the FDA and other regulatory
authorities may not approve F/TAF, E/C/F/TAF and other F/TAF-based
regimens in the currently anticipated timelines or at all, and
marketing approvals, if granted, may have significant limitations
on their use. As a result, F/TAF, E/C/F/TAF and other F/TAF-based
regimens may never be successfully commercialized. In addition,
Gilead may be unable to file for regulatory approval for F/TAF with
other regulatory authorities in the currently anticipated
timelines. 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 Annual Report on Form 10-K for the
year ended December 31, 2014, 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 Viread
and Stribild, including BOXED WARNINGS, is available at
www.gilead.com.
Viread and Stribild are registered trademarks
of Gilead Sciences, Inc., or its related companies.
For more information on Gilead Sciences, please
visit the company’s website at www.gilead.com, follow Gilead on
Twitter (@GileadSciences) or call Gilead Public Affairs at
1-800-GILEAD-5 or 1-650-574-3000.
Gilead Sciences, Inc.Sung Lee, 650-524-7792 (Investors)Ryan
McKeel, 650-377-3548 (Media)
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