According to PharmaLive, a Marketing Authorisation Application (MAA) has been submitted to the European Medicines Agency (EMA) for marketing approval of Quad, a single-tablet regimen of elvitegravir (an integrase inhibitor), cobicistat (a ‘boosting’ agent that enables once-daily dosing of elvitegravir), emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults.  A similar application was submitted to the US FDA in October 2011 (see link to NeLM report).

The MAA is supported by data from two Phase III studies (102 and 103) and by clinical data for the individual components of Quad. Review of the MAA will be conducted under the centralised licensing procedure, which, when finalised, provides one marketing authorisation in all 27 member states of the EU.