May 28, 2015
European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Emtricitabine and Tenofovir Alafenamide for HIV Treatment
– If Approved, Would Provide Potential New Backbone for Future HIV Therapy Combinations –
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.
“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
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
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 (administered as E/C/F/TDF or Stribild®). The MAA is also supported by data from additional Phase 3 studies 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. Lastly, bioequivalence studies demonstrated 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.
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
F/TAF and TAF are investigational products and have not been determined to be safe or efficacious.
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the
possibility that the EMA may not adopt a positive opinion in its
evaluation and the
The European SmPCs for Stribild and Viread are available from the EMA website at www.ema.europa.eu.
Stribild and Viread are registered trademarks of
For more information on
View source version on businesswire.com: http://www.businesswire.com/news/home/20150528005752/en/
Gilead Sciences, Inc.
Patrick O’Brien, +1 650-522-1936
Ryan McKeel, +1 650-377-3548
Kristine Kelly, +44 (0)78 1086 8956