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Investing.com -- GSK plc (LON:GSK) has received U.K. regulatory approval for its oral antibiotic treatment for uncomplicated urinary tract infections (UTIs), marking the first new type of oral antibiotic for this condition in nearly 30 years.
The Medicines and Healthcare products Regulatory Agency (MHRA) approved gepotidacin, marketed as Blujepa, for treating uncomplicated UTIs in females aged 12 years and older who weigh at least 40 kg.
UTIs are the most common bacterial infection in women, affecting approximately half of females in the U.K. The rise of drug-resistant bacteria has made new treatment options essential to prevent treatment failure and 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 involving 3,136 participants, with 1,572 receiving gepotidacin and 1,564 receiving nitrofurantoin, the current frontline antibiotic for uncomplicated UTIs.
The trials showed gepotidacin to be at least as effective as nitrofurantoin, with consistent results across patient groups, including those with recurrent infections and drug-resistant bacteria.
GSK had previously received approval for the medication from the U.S. Food and Drug Administration earlier this year.