Posted by Michael Wonder on 12 Aug 2017
Gilead announces U.S. FDA priority review designation for fixed-dose combination of bictegravir, emtricitabine and tenofovir alafenamide for treatment of HIV
10 August 2017 - Final FDA Decision Anticipated by 12 February 2018.
Gilead Sciences today announced that the U.S. FDA has granted priority review for the company’s new drug application for an investigational, fixed-dose combination of bictegravir, a novel investigational integrase strand transfer inhibitor and emtricitabine/tenofovir alafenamide (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV-1 infection.
Gilead filed the NDA for BIC/FTC/TAF with a priority review voucher on 12 June 2017, and FDA has set a target action date under the Prescription Drug User Fee Act of 12 February 2018.
The application 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 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.
