Gilead Sciences submits application for HIV regimen to FDA

Gilead Sciences, Inc. said it submitted a new drug application to the U.S. Food and Drug Administration (FDA) on July 1 for an investigational, once-a-day single-tablet regimen for the treatment of HIV-1 infection in patients ages 12 and older.

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.
Want to get notified whenever we write about any of these organizations ?
Next time we write about any of these organizations, we'll email you a link to the story. You may edit your settings or unsubscribe at any time.
Organizations in this story

Gilead Sciences, Inc 333 Lakeside Dr Foster City, CA - 94404

U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD - 20903