The U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for Gilead Sciences’s investigational, fixed-dose combination of bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV-1 infection.
Gilead said that it filed the NDA for BIC/FTC/TAF with a Priority Review voucher on June 12, 2017, and FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of February 12, 2018.
The NDA is supported by data from four Phase 3 studies that evaluated the fixed-dose combination among treatment-naïve patients and among virologically suppressed patients. A marketing application for BIC/FTC/TAF is also under review in the European Union, and was validated by the European Medicines Agency (EMA) in July. Bictegravir in combination with FTC/TAF as a single tablet regimen is an investigational treatment that has not been determined to be safe or efficacious and is not approved anywhere globally.