GSK plc (NYSE:GSK) has secured approval in the U.K. for its oral antibiotic aimed at treating uncomplicated urinary tract infections (UTIs), marking the first new oral therapy for this condition in almost 30 years.
The Medicines and Healthcare products Regulatory Agency (MHRA) has cleared gepotidacin, marketed as Blujepa, for use in females aged 12 years and older who weigh at least 40 kg.
UTIs are the most frequently occurring bacterial infection among women, affecting approximately half of the female population in the U.K. With antibiotic resistance on the rise, new treatment options are critical to avoid therapy failures and severe complications, including sepsis or long-term 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,” stated Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access.
The approval is based on two Phase 3 clinical trials involving 3,136 participants—1,572 received gepotidacin, while 1,564 were treated with nitrofurantoin, the current standard antibiotic for uncomplicated UTIs.
Trial results showed that gepotidacin performed at least as well as nitrofurantoin, demonstrating consistent effectiveness across different patient groups, including those with recurrent infections and antibiotic-resistant bacteria.
Earlier this year, GSK also received approval for gepotidacin from the U.S. Food and Drug Administration, highlighting the company’s efforts to expand treatment options for UTIs worldwide.
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