Gilead Sciences’ new HIV therapy accepted for EU review

Gilead Sciences' new emtricitabine/tenofovir alafenamide treatment for HIV has been accepted for European regulatory review.

The company's marketing authorisation application for the investigational fixed-dose F/TAF combination therapy has been fully validated and is now under evaluation by the European Medicines Agency.

This application is supported by data from phase III clinical studies demonstrating the safety and efficacy of the new therapeutic approach.

Gilead is also still awaiting EU approval for a new regime consisting of elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.

Dr Norbert Bischofberger, executive vice-president for research and development and chief scientific officer at Gilead Sciences, said: "F/TAF is the latest advance in Gilead's long history of innovating in HIV therapy and has the potential to become the backbone for the next generation of HIV regimens."

Last month, the company expanded its operational capabilities with the completion of its acquisition of EpiTherapeutics, which specialises in the creation of innovative cancer drugs based on epigenetics.