Gilead Sciences, Inc. (GILD) announced that its Marketing Authorization Application or MAA for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide or F/TAF has been fully validated and is now under evaluation by the European Medicines Agency or 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, the company stated.
TAF is a novel investigational nucleotide reverse transcriptase inhibitor or NRTI that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gilead's Viread, 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 New Drug Applications to the U.S. Food and Drug Administration for E/C/F/TAF and F/TAF on November 5, 2014, and April 7, 2015, respectively.
The MAA for F/TAF is supported by data from Phase 3 clinical studies evaluating the safety and efficacy of E/C/F/TAF for the treatment of HIV-1 infection among treatment-naïve adults, in which the F/TAF-based regimen (administered as E/C/F/TAF) resulted in non-inferior efficacy and improved renal and bone laboratory parameters as compared to F/TDF-based therapy.
F/TAF and TAF are investigational products and have not been determined to be safe or efficacious.
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