25 April 2016 - Gilead Sciences today announced that the European Commission has granted marketing authorization for two doses of Descovy (emtricitabine with tenofovir alafenamide fumarate 200/10 mg and 200/25 mg; F/TAF), a fixed-dose combination for the treatment of HIV-1 infection.
Descovy is Gilead’s second TAF-based therapy to receive marketing authorization in the European Union.
Descovy is indicated in the European Union for the treatment of adults and adolescents (ages 12 years and older with body weight at least 35 kg) in combination with other HIV antiretroviral agents. The marketing authorization is based on a Phase 3 HIV clinical program evaluating F/TAF in combination with other anti-retroviral agents in treatment naïve, virologically suppressed, renally impaired and adolescent patients. The marketing authorization allows for the marketing of Descovy in all 28 countries of the European Union.
For more details, go to: http://www.gilead.com/news/press-releases/2016/4/european-commission-grants-marketing-authorization-for-gileads-fixeddose-combination-descovy-emtricitabine-tenofovir-alafenamide-for-treatment-of-hiv