Gilead Sciences gets marketing authorization from European Commission for Vitekta tablets

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization 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.

"Vitekta offers people with HIV who have failed prior therapy or who have developed drug resistance an important new treatment option," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "Vitekta is only the second integrase inhibitor to become available in the European Union. Today's approval exemplifies Gilead's ongoing commitment to meeting the evolving needs of people living with HIV."

Vitekta has been approved in two doses: an 85 mg tablet is indicated for use with the ritonavir-boosted protease inhibitors atazanavir 300 mg and lopinavir 400 mg; and a 150 mg tablet is indicated for use with the ritonavir-boosted protease inhibitors darunavir 600 mg and fosamprenavir 700 mg. The approval is supported by 96-week data from a Phase 3 study (Study 145) 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 was well tolerated in clinical studies and most adverse reactions were mild to moderate. The most common adverse reactions (all grades) observed were diarrhea (7.1 percent) and nausea (4 percent); please see additional Important Safety Information below.

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 United States in August 2012 for treatment-naïve adults and by the European Commission 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 U.S. Food and Drug Administration (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.