European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Emtricitabine & Tenofovir ...
May 28 2015 - 8:30AM
Business Wire
– If Approved, Would Provide Potential New
Backbone for Future HIV Therapy Combinations –
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the
company’s Marketing Authorization Application (MAA) for two doses
of an investigational fixed-dose combination of emtricitabine and
tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) has been
fully validated and is now under evaluation by the European
Medicines Agency (EMA). The data included in the application
support the use of F/TAF for the treatment of HIV-1 infection in
adults in combination with other HIV antiretroviral agents.
TAF is a novel investigational 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.
“Therapy innovations have transformed HIV into a chronic
condition and people with HIV are living longer, necessitating new
treatment options that deliver on both high efficacy and long-term
safety,” said Norbert Bischofberger, PhD, Executive Vice President,
Research and Development and Chief Scientific Officer, Gilead
Sciences. “F/TAF is the latest advance in Gilead’s long history of
innovating in HIV therapy and has the potential to become the
backbone for the next generation of HIV regimens.”
F/TAF is Gilead’s second F/TAF-based regimen to be validated by
the EMA. An MAA for an investigational once-daily single tablet
regimen containing elvitegravir 150 mg, cobicistat 150 mg,
emtricitabine 200 mg and tenofovir alafenamide 10 mg (E/C/F/TAF)
was fully validated on December 23, 2014. In addition, Gilead filed
New Drug Applications to the U.S. Food and Drug Administration for
E/C/F/TAF and F/TAF on November 5, 2014, and April 7, 2015,
respectively.
The MAA for F/TAF 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 MAA is also supported by data from
additional Phase 3 studies evaluating the F/TAF-based regimen
(administered as E/C/F/TAF) among 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.
Review of the MAA will be conducted by the EMA under the
centralized procedure, which, when finalized, may lead to the grant
of marketing authorization by the European Commission, which is
valid in all 28 member states of the European Union.
F/TAF and TAF are investigational products and have not been
determined to be safe or efficacious.
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. 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 EMA may not adopt a positive
opinion in its evaluation and the European Commission may not grant
marketing authorization. Further, 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 Quarterly Report on Form 10-Q for
the quarter ended March 31, 2015, 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.
The European SmPCs for Stribild and Viread are
available from the EMA website at www.ema.europa.eu.
Stribild and Viread 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20150528005752/en/
Gilead Sciences, Inc.InvestorsPatrick O’Brien, +1
650-522-1936orMedia (U.S.)Ryan McKeel, +1 650-377-3548orMedia
(EU)Kristine Kelly, +44 (0)78 1086 8956
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