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# FDA Approves Janssen’s HIV Drug Symtuza
- URL: https://www.fdaweb.com/fda-approves-janssens-hiv-drug-symtuza/
- Published: 2018-07-18T12:00:00.000Z
- Updated: 2026-09-15T00:20:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141910

FDA has approved a Janssen Pharmaceutical NDA for Symtuza (darunavir), a single-tablet regimen for treating human immunodeficiency virus type 1 in treatment-naïve and certain virologically suppressed adults. Approval was 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 the therapy was effective and well-tolerated, with up to 95% achieving or maintaining virologic suppression, according to the company.