EMA accepts Gilead's filing for HIV drug elvitegravir
This article was originally published in Scrip
Gilead Sciences has reported that its marketing authorisation application (MAA) for elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced patients, has been accepted for review by the European Medicines Agency (EMA). The MAA was submitted under the centralised procedure on 22 May 2012, meaning that a positive decision would lead to approval in all 27 EU member states.
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.
The top-line data from this study were announced in December 2011 (scripintelligence.com, 12 December 2011), with the complete results expected at the International AIDS Conference taking place 22-27 July in Washington, DC.
An MAA for cobicistat, the company's phamacoenhancer or 'boosting' agent, was accepted for EMA review last month (scripintelligence.com, 24 May 2012) and Gilead is waiting for an EMA decision on its Quad single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, for which a filing was accepted on 20December 2011.
Elvitegravir was licensed by Gilead from Japan Tobacco in March 2005. Under the terms of the agreement, Gilead has exclusive rights to develop and commercialise elvitegravir in all countries of the world, excluding Japan, where JT retains the rights.