EMA validates BIC/FTC/TAF marketing application for treatment of HIV

US biotech major Gilead Sciences’ (Nasdaq: GILD) Marketing Authorization Application (MAA) for an investigational, once-daily single tablet regimen containing bictegravir (50mg; BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg; FTC/TAF) for the treatment of HIV-1 infection in adults has been fully validated and is now under evaluation by the European Medicines Agency (EMA).

BIC/FTC/TAF has demonstrated high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in Phase III clinical trials among treatment-naïve adult patients and among virologically suppressed adult patients who switched regimens.

"This investigational single tablet regimen represents a potential advance in HIV treatment by combining the potency of an integrase inhibitor, bictegravir, with the demonstrated safety profile of the FTC/TAF backbone," said Norbert Bischofberger, executive vice president, R&D, and chief scientific officer, Gilead Sciences, adding: "Gilead remains at the forefront of driving innovation in HIV, with our continued commitment to working to simplify and improve treatments for people living with HIV."