European Commission approves once-daily Truvada (emtricitabine 200 mg/tenofovir disoproxil 245 mg; FTC/TDF) for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1.- Gilead Sciences

Gilead Sciences, Inc. 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.