Janssen Cilag files MAA at EMA for once-daily darunavir-based single tablet regimen (DRV,COBI,FTC + TAF) to treat HIV-1.

Janssen-Cilag International NV (Janssen) announced the submission of a Marketing Authorisation Application to the European Medicines Agency (EMA), seeking approval for a new once-daily darunavir-based single tablet regimen (STR). If approved, this tablet would be the first protease inhibitor (PI)-based STR option (D/C/F/TAF FDC), indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (aged 12 years and older with body weight of at least 40 kg).

This new treatment would combine the protease inhibitor, darunavir (DRV, D, 800 mg), with the pharmacokinetic enhancer, cobicistat (COBI, C, 150 mg) and the nucleoside reverse transcriptase inhibitors emtricitabine (FTC, F, 200 mg) and tenofovir alafenamide (TAF 10 mg), in one single tablet. Treatment regimens that combine DRV/COBI (Rezolsta, Janssen-Cilag International NV) and F/TAF (Gilead Sciences International Ltd) are currently approved for the maintenance treatment of HIV. The darunavir STR option is a significant evolution of this approach, combining both treatments in a single, convenient tablet.