MHRA approves UK's first new UTI antibiotic in nearly 30 years

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new oral antibiotic for the treatment of uncomplicated urinary tract infections (UTIs) – the first of its kind in the UK for nearly three decades.

Gepotidacin (Blujepa), suitable for females aged 12 years and over who weigh at least 40kg, targets and blocks two enzymes bacteria need to replicate and multiply, making it effective against many drug-resistant infections.

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The recommended dose is two tablets twice daily for five days, taken approximately every 12 hours.

National approval was supported by two multicentre, randomised trials in females with uncomplicated UTIs, in which 1,572 participants received gepotidacin and 1,564 received nitrofurantoin, the frontline standard treatment.

In both studies, gepotidacin was at least as effective as nitrofurantoin, with consistent results across patient groups, including those with recurrent infections and with drug-resistant bacteria.

The most common adverse effects, which may affect more than one in ten people, were diarrhoea and nausea, both reported as mild.

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Uncomplicated UTIs are the most common bacterial infection in women, affecting around half of females in the UK.

With drug-resistant bacteria on the rise, the MHRA said new treatment options are critical to prevent treatment failure and complications such as sepsis or permanent kidney damage.

Julian Beach, MHRA interim executive director for healthcare quality and access, said: ‘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.

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‘The antibiotic’s targeted mechanism of action makes it more difficult for bacteria to develop treatment resistance.’

The marketing authorisation for the drug was granted to GSK plc. The MHRA said the medicine will continue to be monitored for safety and effectiveness.