Gilead Gets EC Approval for Vitekta

Gilead Sciences has received marketing authorization from the European Commission for Vitekta (elvitegravir 85 mg and 150 mg) tablets, an integrase inhibitor for the treatment of HIV-1 infection in adults without known mutations associated with resistance to elvitegravir.

Vitekta is indicated for use as part of HIV treatment regimens that include a ritonavir-boosted protease inhibitor. Vitekta interferes with HIV replication by blocking the virus from integrating into the genetic material of human cells. In clinical trials, Vitekta was effective in suppressing HIV among patients with drug-resistant strains of HIV.

The approval is supported by 96-week data from a Phase III study in which Vitekta dosed once daily was found to be non-inferior to the integrase inhibitor raltegravir dosed twice daily, each administered with a background regimen that included a fully active ritonavir-boosted protease inhibitor and a second antiretroviral agent. Patients enrolled in the trial were required to have genotypic HIV drug resistance or at least six months of treatment experience with two or more different classes of antiretrovirals.

Vitekta is also a component of Gilead’s Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), a once-daily single tablet regimen for HIV that was approved in the U.S. in August 2012 for treatment-naïve adults and by the EC in May 2013 for adults who are treatment-naïve or who have no known mutations associated with resistance to any of the three antiretroviral agents in Stribild. Gilead submitted a new drug application to the FDA for Vitekta as a single agent in June 2012 and received a Complete Response Letter in April 2013. Gilead is working on resubmitting the application to the FDA.