Posted by Michael Wonder on 21 Jul 2017
Janssen receives positive CHMP opinion for Symtuza the first darunavir based single tablet regimen for the treatment of HIV
21 July 2017 - Proven efficacy and durability of darunavir combined with the improved renal laboratory and bone mineral density profile of emtricitabine/tenofovir alafenamide as compared to emtricitabine/tenofovir disoproxil fumarate into one single tablet.
Janssen-Cilag International NV today announced that the CHMP of the EMA has issued a positive opinion recommending marketing authorisation for Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF]), a once-daily darunavir-based single tablet regimen.
The positive opinion is based on a bioequivalence study comparing the once-daily STR with the combined administration of the separate agents darunavir [D] 800 mg, cobicistat [C] 150 mg, and emtricitabine/tenofovir alafenamide [FTC/TAF] 200 mg/10 mg fixed-dose combination. A Phase 3 clinical trial programme investigating the efficacy and safety of the darunavir-based combination is underway. Data on the bioequivalence study, as well as interim data from the Phase 3 Pivotal EMERALD trial in virologically suppressed antiretroviral therapy experienced patients, who were switched to the STR, will be presented at the upcoming International AIDS Society conference in Paris, France.
