Gilead Sciences has filed a new drug application with the FDA for a once-daily combo tablet as a treatment for adult patients with HIV-1 infection.
The investigational single tablet regimen contains bictegravir and emtricitabine/tenofovir alafenamide. The NDA is supported by encouraging data from four phase III studies in which the regimen met its primary objective of non-inferiority.
Gilead will go head-to-head with GlaxoSmithKline with rival versions of this improved class of HIV medicines.
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