BRIEF—Positive Phase III results with darunavir-based regimen

Janssen Pharmaceutica, a unit of US healthcare giant Johnson & Johnson, today announced that the pivotal Phase III AMBER study achieved its primary endpoint.

This focused on virologic response rate, and demonstrated that the investigational single-tablet regimen (STR) containing darunavir 800mg, cobicistat 150mg, emtricitabine 200mg and tenofovir alafenamide 10mg (D/C/F/TAF) was non-inferior to darunavir/cobicistat (D/C) plus emtricitabine and tenofovir disoproxil fumarate (F/TDF) in previously untreated human immunodeficiency virus type 1 (HIV-1) positive adults.

In the US, D/C/F/TAF is an investigational product. A New Drug Application (NDA) was filed on September 22, 2017 with the Food and Drug Administration. The NDA was filed for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older and was based on the results from two pivotal Phase III studies, EMERALD and AMBER.

On September 25, 2017, the European Commission approved the use of Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF]) for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older with body weight of at least 40kg. This approval allows Janssen to market D/C/F/TAF in all member states of the European Union and the European Economic Area.