Gilead announced that the Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for the investigational single-tablet regimen containing bictegravir, emtricitabine, and tenofovir alafenamide in the treatment of HIV-1 infection.
The investigational fixed-dose treatment combines bictegravir (BIC) 50mg, a novel integrase strand transfer inhibitor (INSTI), with emtricitabine (FTC) 200mg and tenofovir alafenamide (TAF) 25mg, a dual-NRTI backbone. The NDA is supported by data from 4 Phase 3 trials in which the fixed-dose combination was evaluated in both treatment-naïve and virologically suppressed patients.
Gilead expects the FDA to make a decision on the NDA by its Prescription Drug User Fee Act (PDUFA) date of February 12, 2018.
Gilead announces US FDA Priority Review Designation for fixed-dose combination of bictegravir, emtricitabine and tenofovir alafenamide for treatment of HIV [press release]. Foster City, California: Gilead. Published August 10, 2017. Accessed August 30, 2017.
This article originally appeared on MPR