February 01, 2016
European Medicines Agency Validates Gilead’s Type II Variation Application for Truvada® for Reducing the Risk of Sexually Acquired HIV
– If Approved, Truvada Would be First Antiretroviral in Europe to
be Indicated for Use in Combination with Safer Sex Practices to Reduce
the Risk of HIV Infection in Adults –
FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 1, 2016--
Gilead Sciences, Inc. (NASDAQ:GILD) announced today that the company’s
Type II variation application for once-daily Truvada® (emtricitabine
200mg/tenofovir disoproxil fumarate 300mg) 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, has been fully validated and is now under
evaluation by the European Medicines Agency (EMA). Truvada was approved
by the EMA in 2005 in combination with other antiretroviral agents for
the treatment of HIV-1 infection in adults, and is currently the most
prescribed antiretroviral treatment in Europe.
“In Europe, 2014 saw the highest number of HIV diagnoses recorded in any
given year – nearly 30,000 – highlighting the substantial need for
additional strategies to help address the epidemic,” said Sheena
McCormack, Medical Research Council Clinical Trials Unit, University
College London. “We are excited by the potential public health impact
Truvada for PrEP may have, as part of a comprehensive HIV prevention
strategy, in lowering transmission rates among at-risk populations
The application is based on the results of two large placebo-controlled
trials of Truvada for PrEP, the Pre-Exposure Prophylaxis Initiative
(iPrEX) and Partners PrEP, sponsored by the U.S. National Institutes of
Health (NIH) and the University of Washington, respectively. The
indication extension will be reviewed by the EMA under the centralized
procedure, which, when finalized, may lead to the granting of marketing
authorization by the European Commission, which is valid in all 28
member states of the European Union (EU).
In all studies of Truvada for PrEP, 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 an HIV treatment.
“The EMA filing for Truvada for PrEP is timely given the growing body of
evidence supporting its use in preventing HIV and the interest expressed
by the medical and patient advocacy communities,” said Norbert W.
Bischofberger, PhD, Gilead’s Executive Vice President, Research and
Development and Chief Scientific Officer. “Appropriate use of Truvada
for PrEP is supported by European AIDS Clinical Society and World Health
Organization guidelines, and Gilead believes it is an important HIV
prevention tool that, when taken as directed and used in combination
with other prevention strategies, has the potential to help reduce new
Truvada was approved for PrEP in the United States in 2012, and in Kenya
and South Africa in 2015; regulatory submissions are pending in
Australia, Brazil, Canada, Peru and Thailand. Additionally, within the
EU, Truvada for PrEP is currently available in France following a
Temporary Recommendation for Use by the French regulatory agency (ANSM).
Truvada for PrEP is an investigational use in the EU and its safety and
efficacy has not been established.
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.
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
Truvada for PrEP will not be approved by the European Commission or
other regulatory authorities, and any 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
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-5 or 1-650-574-3000
View source version on businesswire.com: http://www.businesswire.com/news/home/20160201005686/en/
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O’Brien, +1
Ryan McKeel, +1 650-377-3548
Stephen Head, +44 (0)7768 705945