Gilead Sciences submits application for HIV regimen to FDA
The regimen combines Gilead's emtricitabine 200 mg and tenofovir alafenamide (TAF) 25 mg with rilpivirine ( R/F/TAF) 25 mg from Janssen Sciences Ireland, UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Gilead said data submitted to the FDA support the use of R/F/TAF among patients who are HIV treatment-naive or who are virologically suppressed and want to replace their current antiretroviral treatment regimen.
"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," Gilead Sciences Executive Vice President of Research and Development and Chief Scientific Officer Norbert Bischofberger said. "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."
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes therapeutics in areas of unmet medical need.