– Gilead’s First TAF-based Single Tablet
Regimen Demonstrates High Efficacy with Improved Renal and Bone
Parameters Compared to TDF-based Regimens –
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the
European Commission has granted marketing authorization for the
once-daily single tablet regimen Genvoya® (elvitegravir 150
mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10
mg or E/C/F/TAF) for the treatment of HIV-1 infection. Genvoya is
the first TAF-based regimen to receive marketing authorization in
the European Union (EU).
Genvoya is indicated in the EU for the treatment of adults and
adolescents (aged 12 years and older with body weight at least
35 kg) infected with HIV-1 without any known mutations
associated with resistance to the integrase inhibitor class,
emtricitabine or tenofovir.
“With access to appropriate treatment, HIV patients today have
the potential to live nearly as long as the general population.
However, research shows they are at an increased risk of age- and
treatment-related comorbidities, which means helping preserve
long-term health should be a priority when making treatment
decisions,” said Anton Pozniak, HIV Service Director, Chelsea and
Westminster Hospital, London, UK. “With Genvoya, we have an
important new treatment option for a range of HIV patients, as it
offers both demonstrated sustained viral suppression and
improvements in renal and bone safety markers compared to TDF-based
regimens.”
Photos and multimedia gallery available at
www.GileadHIVEU.com.
Today’s marketing authorization is based on a Phase 3 HIV
clinical program in more than 3,500 patients across 21 countries,
including treatment-naïve, virologically suppressed, renally
impaired and adolescent patients. It allows for the marketing of
Genvoya in all 28 countries of the EU.
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), as well as 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 lower dose resulting in
91 percent less tenofovir in the bloodstream.
“For more than 25 years, Gilead has continually worked to
develop new treatments to improve the management of HIV,” said
Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President,
Research and Development and Chief Scientific Officer. “Genvoya,
along with other investigational products in our TAF-based
portfolio, have the potential to deliver long-term health benefits
to people living with HIV across Europe and around the world.”
The marketing authorization is supported by 48-week data from
two ongoing Phase 3 studies (Studies 104 and 111) among 1,733
treatment-naïve adult patients in which the regimen met its primary
endpoint of non-inferiority compared to Stribild® (elvitegravir 150
mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir
disoproxil fumarate 300 mg or E/C/F/TDF). In the combined analysis
of the studies, 92.4 percent of Genvoya patients and 90.4 percent
of Stribild patients had HIV-1 RNA levels less than 50 copies/mL at
Week 48. Certain renal and bone laboratory parameters favored
Genvoya over Stribild.
Additionally, the approval is supported by a Phase 3 study
(Study 109) among virologically suppressed adult patients who were
randomized either to stay on their TDF-based regimen or switch to
Genvoya. The study enrolled 1,436 subjects. At Week 48, switching
to Genvoya was found to be statistically superior to remaining on
TDF-based regimens based on the percentages of patients with HIV-1
RNA levels less than 50 copies/mL. Patients receiving Genvoya also
demonstrated improvements in certain bone and renal laboratory
parameters compared to those who stayed on their TDF-based baseline
regimen. Finally, data from two studies evaluating Genvoya among
treatment-naïve adolescents and among virologically suppressed
adult patients with mild-to-moderate renal impairment (eGFR between
30-69ml/min) supported the approval.
For important safety information for Genvoya, including
contraindications, special warnings, drug interactions, and adverse
drug reactions, please see the European SmPC for Genvoya, available
from the EMA website at www.ema.europa.eu.
In addition to Genvoya, two other TAF-based regimens are
currently under evaluation by the EMA. The first is an
investigational, fixed-dose combination of emtricitabine 200 mg and
tenofovir alafenamide 25 or 10 mg (F/TAF) for use in
combination with other antiretroviral agents. The second is an
investigational, once-daily single tablet regimen that combines
emtricitabine 200 mg, tenofovir alafenamide 25 mg and rilpivirine
25 mg (R/F/TAF). Emtricitabine and tenofovir alafenamide are from
Gilead and rilpivirine is from Janssen Sciences Ireland UC, one of
the Janssen Pharmaceutical Companies of Johnson & Johnson.
F/TAF and R/F/TAF are investigational products and their
efficacy and safety have yet not been established in the European
Union.
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 Genvoya may not be approved by other
regulatory authorities and the marketing applications for F/TAF
and/or R/F/TAF may not be approved by the EMA, and marketing
approvals, if granted, may have significant limitations on their
use. 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, 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 Genvoya, Stribild and
Viread are available from the EMA website at www.ema.europa.eu.
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
View source
version on businesswire.com: http://www.businesswire.com/news/home/20151123005550/en/
Gilead Sciences, Inc.InvestorsPatrick O’Brien, +1
650-522-1936orMedia (U.S.)Ryan McKeel, +1 650-377-3548orMedia
(EU)Kristine Kelly, +44 (0) 7810 868 956
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