European CHMP Adopts Positive Opinion for Eviplera®, a Once-Daily Single-Tablet Regimen for the Treatment of HIV Infection
September 23 2011 - 7:12AM
Business Wire
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the
Committee for Medicinal Products for Human Use (CHMP), the
scientific committee of the European Medicines Agency, has adopted
a positive opinion on the company’s Marketing Authorisation
Application for the once-daily single-tablet regimen, Eviplera®,
combining Gilead’s Truvada® (emtricitabine and tenofovir disoproxil
(as fumarate)) with Tibotec Pharmaceuticals’ non-nucleoside reverse
transcriptase inhibitor Edurant® (rilpivirine (as hydrochloride))
for the treatment of HIV-1 infection in antiretroviral-naïve adults
with a viral load less than or equal to 100,000 HIV-1 RNA
copies/mL.
The CHMP’s positive recommendation will be reviewed by the
European Commission, which has the authority to approve medicinal
products for use in the 27 countries of the European Union (EU).
Gilead expects the European Commission to issue its decision on the
marketing authorization for the Eviplera single-tablet regimen
later this year.
“There is a need for the simplification of treatment regimens
featuring co-formulated, fixed-dose medicines as patients stay on
therapy longer,” said John C. Martin, PhD, Chairman and Chief
Executive Officer, Gilead Sciences. “We are pleased to move one
step closer to making this potentially important new simplified
treatment option available to physicians and patients in
Europe.”
The regulatory filing for the Eviplera single-tablet regimen is
supported by 48-week data from two Phase 3 double-blind, active
controlled, randomized studies (ECHO and THRIVE) conducted by
Tibotec evaluating the safety and efficacy of rilpivirine compared
to efavirenz in treatment-naïve HIV-1 infected adults. Both arms of
the studies were administered with a background regimen, in which
the majority of patients in the rilpivirine arm received Truvada. A
bioequivalence study conducted by Gilead demonstrated that the
co-formulated single-tablet regimen achieved the same levels of
medication in the blood as emtricitabine plus rilpivirine plus
tenofovir disoproxil fumarate.
Gilead first entered into a license and collaboration agreement
with Tibotec for the development and commercialization of the
Eviplera single-tablet regimen in July 2009. The product received
regulatory approval from the U.S. Food and Drug Administration
under the trade name Complera™ (emtricitabine/rilpivirine/tenofovir
disoproxil fumarate) in August 2011.
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 worldwide.
Headquartered in Foster City, California, Gilead has operations in
North America, Europe and Asia Pacific.
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.
These risks include the uncertainty of when the European Commission
will issue its decision on the marketing approval of Eviplera, and
that marketing approval, if granted, may have significant
limitations on its 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 June 30, 2011, 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 Complera
is available at www.Complera.com.
U.S. full prescribing information for Truvada
is available at www.Truvada.com.
U.S. full prescribing information for Viread is
available at www.Viread.com.
U.S. full prescribing information for Emtriva
is available at www.GileadHIV.com.
EU Summary of Product Characteristics for
Truvada, Viread and Emtriva are available at
http://www.ema.europa.eu/ema/index.jsp?curl=/pages/home/Home_Page.jsp
Complera, Emtriva, Eviplera, Truvada and Viread
are trademarks or registered trademarks of Gilead Sciences, Inc. or
its related companies.
Edurant is a registered trademark of Tibotec
Pharmaceuticals.
For more information on Gilead Sciences, please
visit the company's website at www.gilead.com or call Gilead Public
Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
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