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Gilead gets EU approval for HIV-prevention treatment Truvada

Published on 23/08/16 at 08:53am

Gilead Sciences has received marketing authorisation from the European Commission for once-daily Truvada (emtricitabine/tenofovir disoproxil), in combination with safer sex practices, for the HIV-prevention strategy known as pre-exposure prophylaxis, or PrEP.

The EU’s Committee for Medicinal Products for Human Use (CHMP) expressed a positive opinion on the drug last month, and this was followed by a landmark UK court ruling that PrEP could be funded on the NHS.

Truvada was approved by the EMA over 10 years ago for use in combination with other retroviral agents for the treatment of HIV-1 infection in adults aged 18 and over. This approval will mean Truvada can be made available for PrEP in all 28 countries in the EU, subject to national regulatory authority approval.

Studies have shown that PrEP can be as much 99% effective in reducing the risk of contracting HIV, even in those at highest risk.

Norbert Bischofberger, chief scientific officer at Gilead, says: “The approval of Truvada for PrEP represents an important step forward in addressing the incidence of HIV in Europe. When taken as directed and used in combination with other prevention strategies, Gilead believes Truvada for PrEP can have a meaningful impact on public health by helping to reduce HIV transmission rates across Europe.”

To read our in-depth feature on PrEP, click here.

Sean Murray

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