Gilead Sciences, Inc.’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 an 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.

F/TAF is Gilead's second F/TAF-based regimen to be validated by the EMA. An MAA for an investigational once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg (E/C/F/TAF) was fully validated on December 23, 2014. In addition, Gilead filed a new drug applications to the US Food and Drug Administration for E/C/F/TAF and F/TAF on November 5, 2014, and April 7, 2015, respectively.

Review of the MAA will be conducted by the EMA under the centralized procedure, which, when finalized, may lead to the grant of marketing authorization by the European Commission, which is valid in all 28 member states of the European Union.

Source: Gilead Sciences