17 July 2018 - Once daily, single-tablet regimen delivers the durability and high barrier to drug resistance of darunavir and the safety profile of tenofovir alafenamide.

Janssen announced the U.S. FDA has approved Symtuza, the first and only complete, darunavir-based single tablet regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults. Symtuza combines the proven high barrier to resistance of darunavir with a formulation designed for improved tolerability and the convenience of a single tablet regimen.

Symtuza received FDA approval based on data from two 48-week, non-inferiority, pivotal Phase 3 studies that assessed the safety and efficacy of Symtuza versus a control regimen in adults with no prior ARV history (AMBER) and in virologically suppressed adults (EMERALD). Results from both trials demonstrated that Symtuza was effective and well-tolerated, with up to 95 percent achieving or maintaining virologic suppression (HIV-1 RNA <50c/mL).

Read Janssen press release