GSK plc (LSE:GSK) has obtained regulatory clearance in the U.K. for its oral antibiotic designed to treat uncomplicated urinary tract infections (UTIs), introducing the first new oral therapy for this condition in nearly three decades.
The Medicines and Healthcare products Regulatory Agency (MHRA) authorized gepotidacin, sold under the brand name Blujepa, for use in females aged 12 and older weighing at least 40 kg.
Urinary tract infections are the most prevalent bacterial infection among women, impacting roughly half of the female population in the U.K. The growing threat of antibiotic-resistant bacteria has made new treatment options vital to avoid treatment failure and prevent serious complications such as sepsis or permanent kidney damage.
“As the first new type of oral antibiotic to treat uncomplicated UTIs to be approved in nearly three decades, gepotidacin provides a new treatment option for women facing urinary tract infections that can severely impact daily life,” said Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access.
The approval follows two Phase 3 clinical trials with a total of 3,136 participants—1,572 received gepotidacin, while 1,564 were treated with nitrofurantoin, the current standard of care for uncomplicated UTIs.
Results demonstrated that gepotidacin was at least as effective as nitrofurantoin, showing consistent efficacy across patient subgroups, including individuals with recurrent infections or drug-resistant bacterial strains.
GSK had earlier secured approval for gepotidacin from the U.S. Food and Drug Administration earlier this year, marking a significant milestone in expanding treatment options for UTIs globally.
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