April 07, 2015
Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide for HIV Treatment
–Potential New Backbone for Future HIV Therapy Combinations–
FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 7, 2015--
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
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,
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
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.
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.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Sung Lee, 650-524-7792 (Investors)
McKeel, 650-377-3548 (Media)