- FDA grants Priority Review to Innoviva's New Drug Application for zoliflodacin, targeting uncomplicated gonorrhea.
- Zoliflodacin, a first-in-class single-dose oral antibiotic, could become the first new treatment for gonorrhea in decades.
- Target Prescription Drug User-Fee Act (PDUFA) date set for December 15, 2025.
The U.S. Food and Drug Administration (FDA) has awarded a Priority Review status to Innoviva Specialty Therapeutics, Inc.'s New Drug Application for zoliflodacin, a pioneering single-dose oral antibiotic designed to treat uncomplicated gonorrhea in both adults and pediatric patients over 12 years old. The FDA has designated a target action date of December 15, 2025, under the Prescription Drug User-Fee Act (PDUFA).
If approved, zoliflodacin would mark a significant milestone as the first new antibiotic available for gonorrhea treatment in several decades. This development is particularly crucial as the bacterium Neisseria gonorrhoeae has shown increasing resistance to existing antibiotics, posing a substantial public health challenge worldwide.
The investigational drug has been granted a Qualified Infectious Disease Product (QIDP) designation by the FDA, which enables it to benefit from Priority Review and Extended Market Exclusivity. Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (INVA, Financial), retains commercial rights in major markets including North America, Europe, and Asia-Pacific, while the Global Antibiotic Research & Development Partnership (GARDP) holds rights in many other countries, including low to middle-income areas.
In pivotal Phase 3 clinical trials, zoliflodacin demonstrated efficacy by achieving microbiological cures comparable to a standard treatment regimen of ceftriaxone and azithromycin, with no serious adverse events reported.
