Gepotidacin (Blujepa) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for use by women and girls from 12 years of age, with a weight of at least 40kg.
The new antibiotic is an oral pill that can be used to treat uncomplicated urinary tract infections (UTIs). It is effective against many drug-resistant infections, including E. coli, using an active ingredient that targets and blocks two enzymes that bacteria need to replicate and multiply.
This type of UTI affects around 50% of women in the UK and is the most common bacterial infection in women. With drug-resistant bacteria increasing, new treatment options are critical in preventing treatment failure and complications, including sepsis or permanent kidney damage.
Julian Beach, MHRA Interim Executive Director, 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.
“The antibiotic’s targeted mechanism of action makes it more difficult for bacteria to develop treatment resistance – a crucial factor as drug-resistant bacteria are increasingly on the rise globally.”
Results from two multicentre, randomised, active-controlled phase 3 trials were used as evidence to support the new drug approval. In the trials, 1,572 participants were given gepotidacin and 1,564 received nitrofurantoin, the current treatment for uncomplicated UTIs.
In both trials, gepotidacin was shown to be at least as effective as nitrofurantoin, with consistent results across patient groups, including those with drug-resistant bacteria and recurrent infections.