Gilead Sciences files emtricitabine and tenofovir alafenamide at EMA for HIV/AIDS.
Gilead Sciences, Inc.announced that the company�s Marketing Authorization Application (MAA) for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) has been fully validated and is now under evaluation by the European Medicines Agency (EMA).
The data included in the application support the use of F/TAF for the treatment of HIV-1 infection in adults in combination with other HIV antiretroviral agents. TAF is a novel investigational nucleotide reverse transcriptase inhibitor (NRTI) that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gilead�s Viread (tenofovir disoproxil fumarate, TDF), as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials.
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