Gilead Gets EMA OK for Antiviral Drug
Gilead Sciences has received marketing authorization from the European Commission 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 human immunodeficiency virus (HIV-1) infection (prophylaxis) among uninfected adults at high risk.
The marketing authorization allows for the marketing of Truvada for prophylaxis in all 28 countries of the European Union (EU), subject to national regulatory authority approval of required pharmacovigilance materials in each country.
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.
In addition to the EU, Truvada is also authorized for prophylaxis in Australia, Canada, Kenya, Peru, South Africa and the US.
Source: Gilead Sciences