European Commission approves Gilead's Truvada for PrEP

The European Commission has granted marketing authorization for US biotech giant Gilead Sciences’ (Nasdaq: GILD) once-daily Truvada(emtricitabine/tenofovir) 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.

"In the past 30 years, we have seen significant progress in the way we treat HIV; however, infection rates have continued to rise. In 2014, we saw the highest number of newly diagnosed cases in the European Union ever recorded, with 94% of those with known cause transmitted through sexual contact," said Professor Jean-Michel Molina, Hôpital Saint Louis in Paris and University of Paris 7, France.