Gilead's Genvoya approved in Europe

The European Commission has granted marketing authorization for US biotech giant Gilead Sciences’ (Nasdaq: GIL) once-daily single tablet regimen Genvoya (elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg or E/C/F/TAF) for the treatment of HIV-1 infection.

Genvoya is the first TAF-based regimen to receive marketing authorization in the European Union. Genvoya is indicated in the EU for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with HIV-1 without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.

Genvoya was the first TAF-based regimen to receive US Food and Drug Administration approval earlier this month (The Pharma Letter November 6).