Gilead Sciences’ elvitegravir accepted for EMEA review

Gilead Sciences has had its new HIV therapy elvitegravir accepted for regulatory review in Europe.

The European Medicines Agency (EMA) has validated the company's marketing authorisation application for the integrase inhibitor, which is specified for use among treatment-experienced HIV-1 patients.

A review of the application will be conducted under the centralised licensing procedure, which will provide a single marketing authorisation for all 27 member states of the EU when finalised.

Gilead Sciences has supported its submission with 96-week data from a phase III clinical trial, during which elvitegravir delivered non-inferior performance compared to the integrase inhibitor raltegravir.

Elvitegravir is one of the components of Gilead's investigational combination HIV therapy Quad, which is also currently under review by the EMA.

Containing cobicistat, emtricitabine and tenofovir disoproxil fumarate, the treatment proved its efficacy compared to alternative therapies in clinical studies published earlier this year.