The European Medicines Agency (EMA) has validated Gilead Sciences’ Type II variation application for once-daily Truvada to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis (PrEP).
In 2005, the EMA approved Truvada (emtricitabine 200mg / tenofovir disoproxil fumarate 300mg) in combination with other antiretroviral agents to treat HIV-1 infection in adults, and is currently the most prescribed antiretroviral treatment in Europe.
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The application was based on the results of two placebo-controlled trials of Truvada for PrEP, the Pre-Exposure Prophylaxis Initiative (iPrEX) and Partners PrEP, sponsored by the US National Institutes of Health (NIH) and the University of Washington, respectively.
The EMA will now review the expanded indication under the centralised procedure, which, when finalised, may lead to the granting of marketing authorisation by the European Commission, which is valid in all 28 member states of the European Union (EU).
In all trials of Truvada for PrEP, the most commonly reported side effects are headache, stomach discomfort and weight loss.
Gilead research and development executive vice-president and chief scientific officer Norbert Bischofberger said: "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.
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By GlobalData"Appropriate use of Truvada for PrEP is supported by European AIDS Clinical Society and World Health Organisation 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 HIV infections."
Truvada was approved for PrEP in the US in 2012, in Kenya and South Africa in 2015, while regulatory submissions are pending in Australia, Brazil, Canada, Peru and Thailand.
In addition, within the EU, Truvada for PrEP is currently available in France following a Temporary Recommendation for Use by the French regulatory agency (ANSM).
Image: Scanning electron micrograph of HIV-1 (in green) budding from cultured lymphocyte. Photo: courtesy of CDC/ C. Goldsmith.
