EMA validates Marketing Application for fixed-dose combination of emtricitabine and tenofovir alafenamide (F/TAF) for HIV treatment
Posted: 29 May 2015 |
Gilead’s MAA for a fixed-dose combination of emtricitabine and tenofovir alafenamide (F/TAF) has been fully validated and is now under evaluation by the EMA..
Gilead’s Marketing Authorisation 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, as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials.
“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,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “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 Gilead’s second F/TAF-based regimen to be validated by the EMA
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 ,cobicistat ,emtricitabine and tenofovir alafenamide (E/C/F/TAF) was fully validated on 23 December 2014. Gilead has filed New Drug Applications to the US Food and Drug Administration for E/C/F/TAF and F/TAF.
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 resulted in non-inferior efficacy and improved renal and bone laboratory parameters as compared to F/TDF-based therapy. The MAA is also supported by data from additional Phase 3 studies evaluating the F/TAF-based regimen (among virologically suppressed adults who switched regimens and adults with mild-to-moderate renal impairment.
Review of the MAA will be conducted by the EMA under the centralised procedure, which, when finalised, may lead to the grant of marketing authorisation by the European Commission, which is valid in all 28 member states of the European Union.
