Gilead Sciences Inc. (GILD) announced it has submitted a New Drug Application or NDA to the U.S. Food and Drug Administration or FDA for marketing approval of elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced adults.
Gilead said Elvitegravir is also a component of the company's once-daily Quad single tablet regimen, which is currently under U.S. and European regulatory review for treatment-naïve adult patients.
The company noted that 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.
Elvitegravir is a member of the integrase inhibitor class of antiretroviral compounds. Unlike other classes, integrase inhibitors interfere with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells. Elvitegravir was licensed by Gilead from Japan Tobacco Inc. or JT in March 2005.
Under the terms of Gilead's agreement with JT, Gilead has exclusive rights to develop and commercialize elvitegravir in all countries of the world, excluding Japan, where JT retains rights.
The Quad contains four Gilead compounds in a complete once-daily, single tablet regimen: elvitegravir 150 mg; cobicistat 150 mg, a "boosting" agent that enables elvitegravir once-daily dosing; and Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg).
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