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U.S. FDA Approves NUZOLVENCE® (zoliflodacin), a First-in-Class, Single-dose, Oral Antibiotic for the Treatment of Uncomplicated Urogenital Gonorrhea in Adults and Adolescents
FDA approval was based on results from the largest Phase 3 clinical trial ever conducted for a new treatment against Neisseria gonorrhoeae infection in
About this update from Innoviva, Inc.
[{"type":"text","content":"\n\nFDA approval was based on results from the largest Phase 3 clinical trial ever conducted for a new treatment against Neisseria gonorrhoeae infection in regions with a high prevalence of gonorrhea across five countries.\n\n\n\nNUZOLVENCE is one of the first new treatments approved by the FDA for uncomplicated urogenital gonorrhea in nearly two decades.\n\n\n\nGonorrhea affects more than 82 million people worldwide each year and is the second most reported bacterial STI in the United States.1,2\n\n\n WALTHAM, Mass.--(BUSINESS WIRE)--\nInnoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (NASDAQ: INVA), today announced that the U.S. Food and Drug Administration (FDA) has approved NUZOLVENCE® (zoliflodacin) for oral suspension, a first-in-class, single-dose oral medication for the treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients 12 years and older weighing at least 35 kg. The development of NUZOLVENCE was part of a private, not-for-profit collaboration with The Global Antibiotic Research and Development Partnership (GARDP), which sponsored and led the Phase 3 clinical trial that supported FDA approval.\n\n“The FDA’s approval of NUZOLVENCE marks a pivotal moment for patients and the broader healthcare community managing gonorrhea infections. For the first time in decades, both patients and their healthcare providers will have a single-dose, oral treatment option for uncomplicated urogenital gonorrhea,” said David Altarac, M.D., Chief Medical Officer, Innoviva Specialty Therapeutics. “This achievement underscores our commitment to advancing innovative therapies for infectious diseases and fighting antimicrobial resistance. It highlights the strength of our development capabilities, as well as our collaboration with GARDP and the global scientific community.”\n\nGonorrhea is the second most common sexually transmitted bacterial infection worldwide, with more than 82 million new cases each year. In the United States alone, the Centers for Disease Control and Prevention (CDC) estimates that over 543,000 cases are reported each year and over 1 million incident cases occur annually,3 underscoring the significant public health impact. The highest rates are seen among sexually active men ages 20-24, though anyone who has unprotected sex can be at risk.4 Without timely treatment, gonorrhea can le...