European Commission Grants Marketing Authorization for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine, Tenofovir ...
April 25 2016 - 7:10AM
Business Wire
– Descovy is the First New HIV Treatment
Backbone Approved in the EU in Over a Decade –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the
European Commission has granted marketing authorization for two
doses of Descovy® (emtricitabine and tenofovir alafenamide 200/10
mg and 200/25 mg; F/TAF), a fixed-dose combination for the
treatment of HIV-1 infection. Descovy is Gilead’s second TAF-based
therapy to receive marketing authorization in the European
Union.
Descovy is indicated in the European Union for the treatment of
adults and adolescents (ages 12 years and older with body
weight at least 35 kg) in combination with other HIV
antiretroviral agents. The marketing authorization is based on a
Phase 3 HIV clinical program evaluating F/TAF in combination with
other antiretroviral agents in treatment naïve, virologically
suppressed, renally impaired and adolescent patients. The marketing
authorization allows for the marketing of Descovy in all 28
countries of the European Union.
“Treatment backbones, paired with a third agent, are a
cornerstone for successful management of HIV. Descovy is the first
new HIV backbone approved in Europe in more than a decade and
represents an important advance in addressing the needs of
patients,” said Dr. José Arribas, Associate Professor of Medicine,
Autonoma University School of Medicine, Madrid. “The components of
Descovy, either as part of a single or multi tablet regimen, offer
physicians and their patients a simple and effective combination
with improvements in renal and bone lab safety parameters.”
TAF is a novel targeted prodrug of tenofovir that has
demonstrated high antiviral efficacy similar to and at a dose less
than one-tenth that of Gilead’s Viread® (tenofovir disoproxil
fumarate; TDF). TAF has also demonstrated improvement in surrogate
laboratory markers of renal and bone safety as compared to TDF in
clinical trials in combination with other antiretroviral agents.
Data show that because TAF enters cells, including HIV-infected
cells, more efficiently than TDF, it can be given at a much lower
dose and there is 90 percent less tenofovir in the bloodstream.
“TAF represents the latest development in Gilead’s more than
25-year history of innovation in the field of HIV, and we are
pleased to offer patients and physicians another TAF-based therapy
that expands their treatment options,” said Norbert Bischofberger,
PhD, Executive Vice President, Research and Development and Chief
Scientific Officer, Gilead Sciences. “We look forward to making
Descovy available as quickly as possible throughout the European
Union as we continue to advance a pipeline of HIV regimens that
contain TAF.”
The marketing authorization for Descovy is supported by 48-week
data from a Phase 3 study (Study 1089) evaluating the safety and
efficacy of switching virologically suppressed HIV-1 infected adult
patients from regimens containing emtricitabine and tenofovir
disoproxil fumarate (F/TDF; Truvada®) plus a third agent to
regimens containing F/TAF plus the same third agent. At Week 48,
the F/TAF-based regimens were found to be statistically
non-inferior to the F/TDF-based regimens, based on percentages of
patients with HIV-1 RNA levels less than 50 copies per mL. The
study also demonstrated statistically significant improvements in
renal and bone laboratory parameters among patients receiving the
F/TAF-based regimens.
The marketing authorization is also supported by 48-week data
from two pivotal Phase 3 studies (Studies 104 and 111) evaluating
an F/TAF-based regimen (administered as Genvoya®; elvitegravir 150
mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10
mg; E/C/F/TAF) against an F/TDF-based regimen (administered as
Stribild®; elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200
mg/tenofovir disoproxil fumarate 300 mg; E/C/F/TDF) among treatment
naïve adult patients. In these studies, certain renal and bone
laboratory parameters favored the F/TAF-based regimen over the
F/TDF-based regimen. Additionally, the marketing authorization is
supported by data from studies evaluating an F/TAF-based regimen
(administered as Genvoya) among adults with mild-to-moderate renal
impairment and among treatment naïve adolescents. Lastly,
bioequivalence studies demonstrated that the formulation of the
fixed-dose combinations of Descovy achieved the same drug levels of
TAF and emtricitabine in the blood as in Genvoya.
For important safety information for Descovy, including posology
and method of administration, special warnings, drug interactions
and adverse drug reactions, please see the European SmPC for
Descovy, available from the EMA website at www.ema.europa.eu.
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 risk that physicians may not see benefits of
prescribing Descovy. 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, 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 Descovy®, Genvoya®,
Stribild® and Viread® are available from the EMA website at
www.ema.europa.eu.
Descovy, Genvoya, 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/20160425005670/en/
Gilead Sciences, Inc.InvestorsPatrick O’Brien, +1
650-522-1936orMedia (U.S.)Ryan McKeel, +1 650-377-3548orMedia
(EU)Stephen Head, +44 (0)7768 705945
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