European Commission grants marketing authorization for Gilead’s once-daily Truvada for reducing the risk of sexually acquired HIV-1

22 August 2016  - Truvada is the first anti-retroviral medicine to be licensed in Europe for pre-exposure prophylaxis, in combination with safer-sex practices, to reduce the risk of sexually acquired HIV-1 in adults at high risk.

Gilead Sciences today announced that the European Commission has granted marketing authorization for once-daily Truvada (emtricitabine 200 mg/tenofovir disoproxil 245 mg; FTC/TDF) 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 European Medicines Agency in 2005 for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults aged 18 years and over, and is currently the most prescribed antiretroviral medicine in Europe as part of combination therapy.

The marketing authorization allows for the marketing of Truvada for PrEP in all 28 countries of the European Union, subject to national regulatory authority approval of required pharmacovigilance materials in each country.

Read Gilead press release

Michael Wonder

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Michael Wonder