European Commission Grants Marketing Authorization for Gilead’s Once-Daily Truvada® For Reducing the Risk of Sexually Acqu...
August 22 2016 - 11:49AM
Business Wire
– Truvada is the First Antiretroviral
Medicine to be Licensed in Europe for Pre-Exposure Prophylaxis, in
Combination with Safer-Sex Practices, to Reduce the Risk of
Sexually Acquired HIV-1 in Adults at High Risk –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the
European Commission has granted marketing authorization for
once-daily Truvada® (emtricitabine 200 mg/tenofovir disoproxil 245
mg; FTC/TDF) in combination with safer-sex practices to reduce the
risk of sexually acquired HIV-1 infection among uninfected adults
at high risk, a strategy known as pre-exposure prophylaxis, or
PrEP. Truvada was approved by the European Medicines Agency in 2005
for use in combination with other antiretroviral agents for the
treatment of HIV-1 infection in adults aged 18 years and over, and
is currently the most prescribed antiretroviral medicine in Europe
as part of combination therapy.
The marketing authorization allows for the marketing of Truvada
for PrEP in all 28 countries of the European Union, subject to
national regulatory authority approval of required
pharmacovigilance materials in each country.
“In the past 30 years, we have seen significant progress in the
way we treat HIV; however, infection rates have continued to rise.
In 2014, we saw the highest number of newly diagnosed cases in the
European Union ever recorded, with 94 percent of those with known
cause transmitted through sexual contact,” said Professor
Jean-Michel Molina, MD, PhD, Hôpital Saint Louis in Paris and
University of Paris 7. “Truvada for PrEP provides an additional
prevention tool, which when used with safer-sex practices, will
help uninfected adults at high risk of HIV protect themselves
against the virus.”
The marketing authorization is based on the results of two large
placebo-controlled trials of Truvada, the Pre-Exposure Prophylaxis
Initiative (iPrEX) and Partners PrEP, sponsored by the U.S.
National Institutes of Health and the University of Washington,
respectively. In these studies, the most commonly reported side
effects included headache, stomach discomfort and weight loss. The
incidence and types of side effects were consistent with Truvada’s
safety and tolerability profile when used as part of an HIV
treatment regimen.
“The approval of Truvada for PrEP represents an important step
forward in addressing the incidence of HIV in Europe” said Norbert
W. Bischofberger, PhD, Executive Vice President, Research and
Development and Chief Scientific Officer, Gilead Sciences. “When
taken as directed and used in combination with other prevention
strategies, Gilead believes Truvada for PrEP can have a meaningful
impact on public health by helping to reduce HIV transmission rates
across Europe.”
Worldwide, clinical guidelines support the use of PrEP, in
combination with other existing prevention measures such as
condoms, to prevent the sexual transmission of HIV in adults at
high risk of HIV infection. Truvada should not be used in
individuals with unknown or positive HIV-1 status, as Truvada alone
does not constitute a complete regimen for the treatment of HIV-1
and HIV-1 resistance mutations have emerged in individuals with
undetected HIV-1 infection who are only taking Truvada.
In addition to the European Union, Truvada is also authorized
for PrEP in Australia, Canada, Kenya, Peru, South Africa and the
United States.
For important safety information for Truvada, including posology
and method of administration, special warnings, drug interactions
and adverse drug reactions, please see the European SmPC, 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 the benefits of
prescribing Truvada for PrEP. 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, 2016, 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 SmPC for Truvada is available from
the EMA website at www.ema.europa.eu.
Truvada is a registered trademark of Gilead
Sciences, Inc.
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-5or 1-650-574-3000
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(U.S.)Ryan McKeel, +1 650-377-3548orMedia (EU)Stephen Head, +44
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