GSK Gepotidacin approved in UK for UTIs in females aged 12 years and older
GSK plc has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for gepotidacin (Blujepa), a new kind of oral antibiotic pill to treat uncomplicated urinary tract infections (UTIs) in females aged 12 years and older, weighing at least 40 kg.
Uncomplicated UTIs are the most common bacterial infection in women, affecting around half of females in the UK. With drug-resistant bacteria increasing, new treatment options are critical in preventing treatment failure and complications, including sepsis or permanent kidney damage.
The active ingredient in the antibiotic targets and blocks two enzymes that bacteria need to replicate and multiply, making it effective against many drug resistant infections such as E. coli.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said, “Keeping patients safe and enabling their access to high quality, safe and effective medicines are key priorities for us.
“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.”
The recommended dose is two tablets twice daily for five days, approximately every 12 hours.
The MHRA’s national approval is supported by evidence from two multicentre, randomised, active-controlled Phase 3 trials in females with uncomplicated UTIs, where 1572 participants were given gepotidacin and 1564 received nitrofurantoin, the frontline antibiotic currently used to treat uncomplicated UTIs.
In both trials, gepotidacin was shown to be at least as effective as nitrofurantoin. Results were consistent across patient groups, including those with recurrent infections, and with drug-resistant bacteria.
The most common side effects of the medicine (which may affect more than 1 in 10 people) include diarrhoea and nausea, both of which were considered mild.
The approval of this gepotidacin follows a rigorous assessment to ensure that it meets the required regulatory standards. As with all medicines, the MHRA will continue to monitor its safety and effectiveness.
"Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card," the release stated.
