GSK PLC on Wednesday announced that the US Food & Drug Administration has accepted its New Drug Application for gepotidacin.
The London-based biopharma company said the FDA has granted a priority review for the application. The FDA has assigned a Prescription Drug User Fee Act action date of March 26 2025.
Gepotidacin is an oral antibiotic for the treatment of uncomplicated urinary tract infections in female adults and adolescents.
GSK said the application was supported by positive results from phase 3 Eagle-2 and Eagle-3 trials. The trials compared the efficacy and safety of gepotidacin to nitrofurantoin, the current standard of care for urinary tract infections.
The results showed gepotidacin to be ‘significantly’ more effective than nitrofurantoin in treating urinary tract infections.
In Eagle-3 gepotidacin demonstrated success in 59% of participants compared to 44% for nitrofurantoin. In Eagle-2 gepotidacin demonstrated success in 51% of participants compared to 47% for nitrofurantoin.
GSK noted that over half of all women are affected by urinary tract infections in their lifetime, with approximately 30% suffering from recurrent disease.
The company highlighted the need for new treatments due to an increased number of urinary tract infections caused by drug-resistance bacteria.
GSK said gepotidacin ‘could be the first in a new class of oral antibiotics for uncomplicated urinary tract infections in over 20 years’.
GSK shares were up 0.4% to 1,499.19 pence each in London on Wednesday morning.
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