Gilead Sciences, Inc. (Nasdaq:GILD) announced today that its Marketing Authorisation Application (MAA) for elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced patients, has been validated by the European Medicines Agency (EMA). Gilead submitted the MAA on May 22, 2012. Review of the MAA will be conducted under the centralized licensing procedure, which, when finalized, provides one marketing authorization in all 27 member states of the European Union (EU).
The MAA 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 ritonavir-boosted protease inhibitor and a second antiretroviral. Topline 96-week data from this study were announced in December 2011, and complete results will be presented at the XIX International AIDS Conference taking place July 22-27 in Washington, D.C.
Gilead's marketing application for the Quad single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate was validated by EMA on December 20, 2011. Additionally, an MAA for cobicistat, our phamacoenhancer or "boosting" agent that increases blood levels of certain commercially available protease inhibitors and has no antiviral activity, was validated by EMA on May 22, 2012.
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