August 22, 2016
European Commission Grants Marketing Authorization for Gilead’s Once-Daily Truvada® For Reducing the Risk of Sexually Acquired HIV-1
– Truvada is the First Antiretroviral Medicine to be Licensed in
The marketing authorization allows for the marketing of Truvada for PrEP
in all 28 countries of the
“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
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
“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,
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
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.
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
The European SmPC for Truvada is available from the EMA website at www.ema.europa.eu.
Truvada is a registered trademark of
For more information on
Gilead Sciences, Inc.
Sung Lee, +1 650-524-7792
Ryan McKeel, +1 650-377-3548
Stephen Head, +44 (0)7768 705945