EMA accepts Gilead's filing for HIV drug elvitegravir
This article was originally published in Scrip
Executive Summary
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.