The tablet combines Gilead’s emtricitabine 200mg and tenofovir alafenamide (TAF) 25mg with Janssen Sciences Ireland’s rilpivirine 25mg (R/F/TAF).
The company said that the data submitted in the NDA support the use of R/F/TAF among patients who are HIV treatment-naïve or who are virologically suppressed and want to replace their current antiretroviral treatment regimen.
Along with the R/F/TAF NDA, a Priority Review voucher acquired from Knight Therapeutics in November 2014 was submitted to the FDA.
The anticipated target action date for the R/F/TAF NDA under the Prescription Drug User Fee Act (PDUFA) is six months after the FDA’s acceptance of the filing.
Gilead Sciences Research and Development executive vice-president and chief scientific officer Norbert Bischofberger said: "R/F/TAF is Gilead’s third TAF-based filing in less than a year, and we are looking forward to the potential to offer people living with HIV another effective treatment option with a favorable safety profile.
"The R/F/TAF filing also represents Gilead’s next collaboration with Janssen in our combined efforts to increase and potentially improve HIV treatments for a range of patients."
TAF is a new, investigational nucleotide reverse transcriptase inhibitor (NRTI) that has shown high antiviral efficacy at a dose less than one-tenth that of Gilead’s Viread (tenofovir disoproxil fumarate, TDF).
Apart from R/F/TAF, two other TAF-based HIV treatments are also under FDA review.
The NDA is based on data from a bioequivalence study which showed that R/F/TAF achieved the same drug levels of emtricitabine and TAF in the blood as E/C/F/TAF (10mg TAF dosage) and the same drug levels of rilpivirine as a 25mg dose of rilpivirine (Edurant) alone.