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