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Gilead Submits Elvitegravir NDA

By Drug Discovery Trends Editor | June 28, 2012

Gilead Sciences Inc. 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.

Date: June 27, 2012
Source: Gilead Sciences Inc.


Filed Under: Drug Discovery

 

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