The Janssen Pharmaceutical Companies of Johnson & Johnson have announced the U.S. Food and Drug Administration (FDA) has approved SYMTUZA™, the first and only complete, darunavir-based single-tablet regimen (STR) 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 an STR.
The U.S. Department of Health and Human Services guidelines recommend darunavir-based therapies for treatment-naïve patients in certain clinical situations, including when a person may have uncertain adherence or when ARV treatment should be initiated before resistance test results are available.
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.
Joseph Eron, M.D., Professor of Medicine and Director, Clinical Core, University of North Carolina Center for AIDS Research, Chapel Hill, N.C said, “As clinicians, we may not always have the full picture of a patient’s health or their risk for developing resistance when making treatment decisions. In key Phase 3 clinical trials, SYMTUZA™ successfully treated those who were starting therapy, as well as those who were stably suppressed on antiretroviral (ARV) therapy. Many people living with HIV struggle to adhere to their medication, which can lead to the development of drug resistance and potentially cause their medication to stop working.”
Brian Woodfall, M.D., Global Head of Late Development, Infectious Diseases, Janssen Pharmaceutica NV said, “The FDA approval of SYMTUZA™ marks another important milestone in our quest to address real-world clinical challenges, combat HIV drug resistance and meet the diverse needs of those living with HIV.”