Gilead Sciences receives EU approval for new HIV therapy Genvoya

Gilead Sciences has announced that its new combination HIV therapy Genvoya has been approved by the European Commission.

The once-daily single tablet regimen combines elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide, and represents the first tenofovir alafenamide-based therapy to be approved in the EU.

It is indicated for the treatment of adults and adolescents infected with HIV-1 without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.

This approval is based on positive data from a phase III HIV clinical programme involving more than 3,500 individuals across 21 countries, including treatment-naive, virologically suppressed, renally impaired and adolescent patients.

Dr Norbert Bischofberger, Gilead's executive vice-president for research and development and chief scientific officer, said: "Genvoya, along with other investigational products in our TAF-based portfolio, have the potential to deliver long-term health benefits to people living with HIV across Europe and around the world."

The company also received US regulatory approval for Genvoya last month.