Gilead Sciences announced it has submitted a New Drug Application (NDA) to the FDA for marketing approval of elvitegravir for the treatment of HIV-1 infection in treatment-experienced adults.
The NDA for elvitegravir is supported by 96-week data from a pivotal Phase 3 study (Study 145) in which elvitegravir (150mg or 85mg) dosed once daily was non-inferior to 400mg of the integrase inhibitor raltegravir (Isentress; Merck & Co., Inc.) dosed twice daily, each administered with a background regimen that included a fully active ritonavir (Norvir; Abbott Laboratories)-boosted protease inhibitor and a second antiretroviral.
Elvitegravir is a member of the integrase inhibitor class of antiretroviral compounds. Integrase inhibitors interfere with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells.
For more information call (800) GILEAD-5 or visit www.gilead.com.