EMA accepts application for elvitegravir(Gilead Sciences) for HIV-1 treatment

The European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced patients,from Gilead Sciences. The filing for elvitegravir was supported by 96-week data from a pivotal Phase III study (Study 145) in which the product (150mg or 85mg) dosed once daily was shown to be non-inferior to the integrase inhibitor raltegravir (Merck & Co's Isentress; 400mg dosed twice daily), when each was administered with a background regimen that included a ritonavir-boosted protease inhibitor and a second antiretroviral.