EMA Recommends Approval of First HIV Pre-Exposure Prophylaxis Drug in the EU

July 22, 2016
Pharmaceutical Technology Editors

The agency has recommended granting marketing authorization in the EU for Truvada.

The European Medicines Agency (EMA) announced on July 22, 2016 that it was recommending marketing authorization for Truvada (emtricitabine/tenofovir disoproxil) in the European Union. Truvada is taken as a pre-exposure prophylaxis (PrEP) measure to reduce the risk of sexually-acquired HIV type 1 (HIV-1) infection in adults at high risk.

Truvada is the first drug to be approved in the EU for PrEP and is used as a part of an overall HIV infection prevention strategy that includes safe-sex practices, including the use of condoms.

Truvada was originally authorized in the EU in 2005 to treat HIV-1 infection in adults in combination with other antiviral medications. According to EMA, “Truvada contains two active substances, emtricitabine and tenofovir disoproxil, which is a ‘prodrug’ of tenofovir. This means that it is converted into tenofovir in the body. Emtricitabine and tenofovir work in similar ways by blocking the activity of viral reverse transcriptase, which is necessary for the virus to multiply.”

Studies showed substantial reduction in the risk of HIV-1 when Truvada was used as a prophylactic. In one study, the drug reduced the risk of HIV infection in 2499 HIV-negative men and transgender women who have sex with men by 42%, compared with placebo. Truvada reduced the risk of infection by 75% in the second study, which involved 4758 heterosexual couples where one partner was HIV-positive and the other was not. The study also evaluated the efficacy and safety of Truvada or tenofovir alone versus placebo.

Source: EMA