Gilead submits elvitegravir NDA with FDA for treatment of HIV-1 infection

Gilead Sciences, Inc. (Nasdaq:GILD) announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced adults. Elvitegravir is also a component of Gilead's once-daily Quad single tablet regimen, which is currently under U.S. and European regulatory review for treatment-naïve adult patients.

The NDA for elvitegravir is supported by 96-week data from a pivotal Phase 3 study (Study 145) in which elvitegravir (150 mg or 85 mg) dosed once daily was non-inferior to the integrase inhibitor raltegravir (400 mg) dosed twice daily, each administered with a background regimen that included a fully active ritonavir-boosted protease inhibitor and a second antiretroviral.