The data included in the MAA support the use of F/TAF to treat HIV-1 infection in adults in combination with other HIV antiretroviral agents.
TAF is a new investigational nucleotide reverse transcriptase inhibitor (NRTI) that has showed high antiviral efficacy at a dose less than one-tenth that of the company’s Viread (tenofovir disoproxil fumarate, TDF), as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials.
Gilead Sciences Research and Development executive vice-president and chief scientific officer Norbert Bischofberger said: "Therapy innovations have transformed HIV into a chronic condition and people with HIV are living longer, necessitating new treatment options that deliver on both high efficacy and long-term safety.
"F/TAF is the latest advance in Gilead’s long history of innovating in HIV therapy and has the potential to become the backbone for the next generation of HIV regimens."
F/TAF is the company’s second F/TAF-based regimen to be validated by the EMA.
Last December, an MAA for an investigational once-daily single tablet regimen containing elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg and tenofovir alafenamide 10mg (E/C/F/TAF) was fully validated.
Additionally, the company has filed new drug applications to the US Food and Drug Administration (FDA) for E/C/F/TAF and F/TAF on 05 November 2014 and 07 April 2015, respectively.
The MAA for F/TAF is based on data from Phase III clinical trials evaluating the safety and efficacy of E/C/F/TAF to treat 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 (administered as E/C/F/TDF or Stribild).
The application is also supported by data from additional Phase III trials evaluating the F/TAF-based regimen (administered as E/C/F/TAF) among virologically suppressed adults who switched regimens and adults with mild-to-moderate renal impairment.
Bioequivalence studies also showed that the formulation of the fixed-dose combinations of F/TAF achieved the same drug levels in the blood as in E/C/F/TAF.
The EMA will carry out the review of the MAA under the centralized procedure, which, when finalized, may lead to the grant of marketing authorization by the European Commission (EC), which is valid in all 28 member states of the European Union (EU).