Gilead Wins EC Marketing Authorization for HIV-1 Drug

The European Commission has awarded Gilead Sciences marketing authorization for its HIV-1 infection treatment Genvoya.

A once-daily single tablet regimen, Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) is indicated in the EU for adults and children ages 12 and older who are infected with HIV-1 without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.

The authorization is based on Phase 3 studies of more than 3,500 patients in 21 countries. The FDA also has approved the drug.