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news.Gilead Sciences has been granted marketing authorization by the European Commission for its once-a-day anti-HIV combination treatment, Truvada, making it the company's fourth antiviral to be granted marketing authorization in Europe in three years.
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Truvada, which combines the company’s anti-HIV medications Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate) in one tablet, has now been granted marketing approval in all 25 member states of the European Union.
In the EU, 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 Emtriva and Viread in antiretroviral therapy in treatment-naive patients.
As Truvada contains emtricitabine and tenofovir disoproxil fumarate, the guidance for physicians in the Truvada summary of product characteristics (SmPC) is consistent with the guidance in the SmPCs of Emtriva and Viread. A European SmPC is similar to a product’s prescribing information in the US.
“This approval marks an important milestone in the company’s mission to advance the care of people living with HIV,” said Dr John Martin, president and CEO of Gilead. “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.”
Gilead submitted a marketing authorization application (MAA) for Truvada in March 2004 and the EMEA’s European Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion of Truvada in November 2004.