Rilpivirine/FTC/TAF becomes the third TAF-based fixed dose combination submitted for US approval

On 1 July 2015, Gilead submitted a new drug application to the US FDA for a fixed dose combination tablet that contains rilpivirine, FTC and tenofovir alafenamide fumerate (TAF). [1]

As a priority review, the FDA decision is expected within six months of the filing.

This is the third filing that includes the new TAF formulation of tenofovir. The FDA dates for the two previous submissions are 5 November 2015 for elviregravir/cobicistat/FTC/TAF (E/C/F/TAF) and 7 April 2016 for the dual formulation of FTC/TAF (F/TAF).

Applications in the European Union (EU) were validated on 23 December 2014 for E/C/F/TAF and on 28 May 2015 for F/TAF. The EU application for R/F/TAF is due to be filed in the third quarter of 2015.

Gilead press statement. Gilead submits new drug application to U.S. Food and Drug Administration for single tablet regimen for HIV containing rilpivirine, emtricitabine and tenofovir alafenamide (R/F/TAF). (01 July 2015).