FDA Grants Priority Review to Single Tablet HIV Regimen

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Gilead expects the FDA to make a decision on the NDA by February 12, 2018.
Gilead expects the FDA to make a decision on the NDA by February 12, 2018.

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.

Reference

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.

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