Janssen-Cilag International (Janssen) has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorisation for Symtuza for the treatment of HIV.
Symtuza (darunavir / cobicistat / emtricitabine / tenofovir alafenamide) is a once-daily, darunavir-based single tablet regimen (STR).
If approved, Symtuza will be the only darunavir-based STR indicated to treat human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents aged 12 and older with a body weight of at least 40kg, with genotypic testing guiding use.
The STR combines the efficacy and durability of darunavir with the improved renal laboratory and bone mineral density profile of F/TAF as compared to F/TDF (tenofovir disoproxil fumarate).
Janssen infectious diseases therapeutics global therapeutic area head Lawrence Blatt said: "Darunavir is one of the most widely used HIV treatments in the European Union due to its ability to control the HIV virus while offering a high barrier to resistance.
"We will now be able to combine a complete darunavir-based HIV treatment regimen into a once-daily tablet. We are extremely excited to be one step closer to getting this therapy to people living with HIV and in doing so hope to reduce the treatment burden faced by many living with the virus."
The decision was based on a bioequivalence study, which compared the once-daily STR with the combined administration of the separate agents darunavir at 800mg, cobicistat at 150mg, and a fixed-dose combination of emtricitabine / tenofovir alafenamide at 200mg / 10mg.
The efficacy and safety of the darunavir-based combination is currently being evaluated in a Phase III clinical trial programme.