The clearance was based on two late-stage Phase 3 trials involving more than 3,100 patients, where Blujepa proved at least as effective as the current standard treatment, even in women with recurrent or drug-resistant infections.
GSK has secured UK approval for Blujepa (gepotidacin), the first new type of oral antibiotic for urinary tract infections (UTIs) to be cleared in nearly three decades as the drugmaker seeks to grow its infectious disease portfolio.
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s medicines regulator, has approved Blujepa for use in women and girls aged 12 and older, weighing at least 40 kilos, to treat simple urinary tract infections.
UTIs are the most common bacterial infection in women in the UK, with about half of all women in the UK being affected by them. However, patients are at an increasing risk of failure and serious complications, including sepsis and kidney damage, as antibiotic resistance increases.
Blujepa acts in a novel way by blocking two bacterial enzymes essential for bacterial replication. It can therefore act on antibiotic-resistant strains such as E. coli.
“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, Interim Executive Director at the MHRA.
The recommended regimen is two tablets twice daily for five days. The approval was based on results from two late-stage Phase 3 studies involving more than 3,100 patients.
In those trials, Blujepa was at least as effective as nitrofurantoin, the current standard treatment, even in women with recurrent infections and resistant bacteria, with consistent results.
The most common side effects were mild diarrhoea and nausea, affecting more than one in ten patients.
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