Insight on FDA Approval of Symtuza for Treatment of HIV Infection

The US Food and Drug Administration (FDA) has approved what its manufacturer calls “the first and only complete, darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naive and certain virologically suppressed adults.” Using the brand name Symtuza and made by Janssen Pharmaceuticals, the drug combo “combines the proven high barrier to resistance of darunavir with a formulation designed for improved tolerability and the convenience of an STR.”

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).

SYMTUZA™ has also been approved by the European Commission (EC) and Health Canada for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older with body weight of at least 40 kg.