Gilead Sciences has been granted a marketing authorisation for Truvada (emtricitabine and tenofovir disoproxil fumarate) by the European Commission in all 25-member states of the European Union. Truvada combines the company's anti-HIV medications Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate) in one tablet, taken once a day in combination with other antiretroviral agents.

In the European Union, Truvada is indicated for the treatment of HIV-infected adults in combination with other antiretroviral agents. This indication is based on the demonstration of the benefit of the combination of emtricitabine and tenofovir disoproxil fumarate in antiretroviral therapy in treatment-naive patients, according to company sources.

Gilead submitted a Marketing Authorisation Application (MAA) for Truvada on March 12, 2004 under the centralized procedure. The European Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), gave a positive opinion of Truvada on November 18, 2004. This is the company's fourth antiviral to be granted marketing authorisation in Europe in three years.

John C. Martin, president and CEO of Gilead said, "By combining two of the three drugs necessary for triple-drug therapy into a single once-a-day tablet, Truvada provides an important option for doctors and patients looking to construct simplified combination regimens."