European CHMP Adopts Positive Opinion on Gilead’s Type II Variation Application for Truvada® for Reducing the Risk of Sexu...
July 22 2016 - 7:17AM
Business Wire
– If Approved, Truvada for PrEP in
Combination with Safer Sex Practices Could Offer Uninfected Adults
at High Risk a New Option to Reduce the Risk of Acquiring HIV
–
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 (EMA), has
adopted a positive opinion on the company’s Type II variation
application for once-daily Truvada® (emtricitabine 200 mg/tenofovir
disoproxil 245 mg) 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 EMA in 2005 for
use in combination with other antiretroviral agents for the
treatment of HIV-1 infection in adults, and is currently the most
prescribed antiretroviral medicine in Europe as part of combination
therapy.
The CHMP’s recommendation will now be reviewed by the European
Commission, which has the authority to approve medicines for use in
the 28 countries of the European Union (EU).
The Type II variation 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 and the
University of Washington, respectively. In 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 part of an HIV treatment regimen.
“The CHMP’s opinion moves the medical community closer to being
able to offer an additional HIV prevention tool to people at high
risk of HIV acquisition across the entire EU,” said Professor
Jean-Michel Molina, MD, PhD, Hôpital Saint Louis in Paris and
University of Paris 7. “Evidence supports pre-exposure prophylaxis,
in combination with safer sex practices, to reduce the risk of
sexually acquired HIV and we look forward to the potential public
health impact of PrEP, in addition to increasing access to testing
and universal treatment of people living with the disease, in
helping to lower HIV transmission rates in Europe.”
Worldwide, clinical guidelines support the use of PrEP, in
combination with existing prevention measures such as condoms, to
prevent the sexual transmission of HIV in adults at high risk of
HIV infection. Truvada for PrEP 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. Truvada is approved
for PrEP in Australia, Canada, Kenya, Peru, South Africa and the
United States. Regulatory submissions are pending in Brazil, Taiwan
and Thailand. Additionally, within the EU, Truvada is currently
available for PrEP in France under a Temporary Recommendation for
Use by the French regulatory agency (ANSM).
The use of Truvada for PrEP is investigational in the EU and its
safety and efficacy have not been established.
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 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 March 31, 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-5 or 1-650-574-3000.
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Gilead Sciences, Inc.InvestorsSung Lee, +1 650-524-7792orMedia
(U.S.)Ryan McKeel, +1 650-377-3548orMedia (EU)Stephen Head, +44
(0)7768 705945
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