European CHMP Adopts Positive Opinion on Gilead’s Type II Variation Application for Truvada® for Reducing the Risk of Sexually Acquired 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.
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 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.
Gilead Sciences, Inc.
Sung Lee, +1 650-524-7792
Ryan McKeel, +1 650-377-3548
Stephen Head, +44 (0)7768 705945
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