Gilead submits new HIV drug application to FDA

Gilead submits new HIV drug application to FDA
Gilead submits new HIV drug application to FDA | Courtesy of
Gilead Sciences Inc. recently announced that it has submitted to the United States Food and Drug Administration (FDA) a New Drug Application (NDA) for a once-daily single tablet regiment for HIV.

The drug being investigated is a combination of Gilead’s emtricitabine 200 mg and Janssen Sciences Ireland UC’s tenofovir alafenamid (TAF) 25 mg rilpivirine 25 mg (R/F/TAF). Janssen Sciences Ireland is a branch of the Janssen Pharmaceutical Companies under Johnson & Johnson.

The purpose of the drug is to treat both adult and pediatric patients between the ages of 12 years and above who have HIV-1 infections. Current data included in the NDA suggests that using R/F/TAF with patients who classify as virologically suppressed or HIV treatment-naïve may be effective in substituting 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,” Dr. Norbert Bischofberger, executive vice president of research and development and chief scientific officer, Gilead Sciences, 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.”