The U.S. Food and Drug Administration (FDA) has approved Janssen’s 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 has a Boxed Warning regarding the risk of post-treatment acute exacerbation of hepatitis B.
“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,” said Joseph Eron, M.D., professor of medicine and director, clinical core, University of North Carolina Center for AIDS Research, Chapel Hill, N.C. “In key Phase 3 clinical trials, Symtuza successfully treated those who were starting therapy, as well as those who were stably suppressed on antiretroviral therapy—including patients with more complex treatment histories or previous virologic failure—demonstrating its potential as an important new treatment option for a wide variety of patients.”
The U.S. Department of Health and Human Services guidelines1 recommend darunavir-based therapies for treatment-naïve patients in certain clinical situations, including when a person may have uncertain adherence or when antiretroviral 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 antiretroviral 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 also has 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. European approval allows Janssen to market Symtuza in all member states of the European Union and the European Economic Area.
Janssen plans additional regulatory filings in other markets worldwide, and additional Symtuza data, including data from an ongoing Phase 3 rapid initiation study (DIAMOND) will be presented at AIDS 2018 in Amsterdam, The Netherlands, in late July.
Cobicistat, emtricitabine and tenofovir alafenamide are from Gilead Sciences, Inc.
Filed Under: Drug Discovery