GSK has received UK approval for Blujepa (gepotidacin), the first new oral antibiotic for urinary tract infections (UTIs) in nearly 30 years. The MHRA has authorized its use in women and girls aged 12 and above (weighing at least 40 kg) for the treatment of uncomplicated UTIs.
UTIs are among the most common bacterial infections in women, but rising antibiotic resistance has increased risks of treatment failure and complications such as sepsis and kidney damage. Blujepa works by blocking two key bacterial enzymes required for replication, making it effective against resistant strains like E. coli.
The approval follows results from two Phase 3 trials with over 3,100 patients, where Blujepa proved at least as effective as nitrofurantoin, even in recurrent or resistant cases. The treatment regimen is two tablets twice daily for five days.
The most frequently reported side effects were mild diarrhea and nausea, occurring in more than 10% of patients.