Regulators in Europe have given the green light to Gilead Sciences' Vitekta as part of HIV treatment regimens that include a ritonavir-boosted protease inhibitor.
Vitekta (elvitegravir) has been approved for two doses: an 85mg tablet is indicated for use with Reyataz (atazanavir) and lopinavir, while a 150mg pill can be used with Prezista (darunavir) and Lexiva/Telzir (fosamprenavir). The approval is supported by a Phase III study in which Vitekta dosed once-daily was found to be non-inferior to the integrase inhibitor Isentress (raltegravir), taken twice-daily.
Vitekta is also a component of Gilead's Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil), a once-daily single tablet regimen for HIV that received US. approval in August 2012 and a European Commission green light in May 2013. Gilead chief scientific officer Norbert Bischofberger, noting that Vitekta is the second integrase inhibitor to become available in the European Union, said the drug "offers people with HIV who have failed prior therapy or who have developed drug resistance an important new treatment option".
This is good news for the firm, given that US regulators turned down Vitekta as a single agent in April, noting deficiencies in documentation amongst other things. Gilead says it is working on resubmitting the application to the FDA.
Vitekta was licensed by Gilead from Japan Tobacco in March 2005. It has exclusive rights to develop the drug as a single agent worldwide outside Japan, where JT retains rights.