GSK’s shares rose 0.8% to £14.07 in London after the U.S. FDA granted priority review for its antibiotic Gepotidacin, targeting uncomplicated urogenital gonorrhea. Currently, patients rely on painful injections, as no oral treatment exists. With over 600,000 U.S. cases reported in 2023, the potential market for an effective pill is substantial. GSK’s Phase III Eagle-1 trial data supported the application, with a final FDA decision expected by December 2025.
Strategic Market Entry Ahead
If approved, Gepotidacin—already cleared for urinary tract infections under the brand Blujepa—would be the first oral gonorrhea treatment in the U.S., addressing a critical gap in care. The antibiotic’s development was partly funded by U.S. federal health agencies, underscoring its strategic importance. Parallel approvals are underway in the UK and Australia, positioning GSK to capitalize on a high-demand therapeutic area. The priority review status reflects confidence in the drug’s potential to reshape treatment standards and drive significant revenue.
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