Gilead Pharmaceuticals’ used a priority review voucher to expedite the FDA’s assessment of a combination HIV-1 treatment including bictegravir, emtricitabine and tenofovir alafenamide. The agency set a target action date of Feb. 12, 2018.
The company backed up the NDA with data from four Phase III studies of the combination’s effect on virologically suppressed and treatment-naïve patients. The European Union is also currently reviewing a marketing application for the therapy.
Gilead filed its voucher and application for the single-tablet regimen in June. Bictegravir is a novel integrase strand transfer inhibitor, and the fixed-dose combination has not yet been approved anywhere internationally.