The Medicines and Healthcare products Regulatory Agency (MHRA) yesterday (August 28) announced that it has approved the “first new type of antibiotic” for urinary tract infections (UTIs) in almost 30 years.
Gepotidacin, manufactured by GSK under brand name Blujepa, is an oral antibiotic pill for treating uncomplicated UTIs in females aged 12 years and older, weighing at least 40kg.
The active ingredient in the drug “targets and blocks two enzymes that bacteria need to replicate and multiply”, which makes it “effective against many drug-resistant infections such as E. coli”, the regulator said.
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The recommended dose is “two tablets twice daily for five days, approximately every 12 hours” and the most common side effects include mild diarrhoea and nausea, it added.
The MHRA stressed that the approval follows a “rigorous assessment” and that it will continue to monitor the drug’s “safety and effectiveness”.
“Targeted mechanism”
Uncomplicated UTIs affect roughly half of all females in the UK, making them the most common bacterial infection in women, according to the MHRA.
As drug-resistant bacteria continue to pose a major global health threat, new treatment options are crucial in “preventing treatment failure and complications including sepsis or permanent kidney damage”, it added.
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“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 UTIs that can severely impact daily life,” said MHRA interim executive director of healthcare quality and access Julian Beach.
He added that gepotidacin’s “targeted mechanism of action”, which makes it harder for bacteria to become resistant to treatment, is “a crucial factor as drug-resistant bacteria are increasingly on the rise globally”.
“At least as effective”
The drug’s approval follows “two multicentre randomised active-controlled Phase 3 trials in females with uncomplicated UTIs”, with 1,572 participants given gepotidacin and 1,564 nitrofurantoin - the frontline antibiotic currently used to treat the condition – the MHRA said.
Both trials found gepotidacin to be “at least as effective as nitrofurantoin”, with consistent results across the patient groups studied “including those with recurrent infections and with drug-resistant bacteria”, it added.
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While gepotidacin has been approved by the MHRA, it must be recommended by the National Institute for Health and Care Excellence (NICE) before it can become available on the NHS.
As such, NHS England (NHSE) told C+D it is “too early” to comment on whether the antibiotic will be used under the Pharmacy First scheme, which allows pharmacists to provide treatment for seven common health conditions including uncomplicated UTIs.
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The drug’s approval comes after the Massachusetts Institute of Technology (MIT) this month revealed that it has designed “novel antibiotics” to combat drug-resistant bacteria for infections like gonorrhoea and MRSA.
Earlier this year, the National Audit Office (NAO) announced that the UK remains “a long way from” plans made to “control, contain and mitigate” antimicrobial resistance (AMR).
An investigation by the independent public spending watchdog found that the government has made “limited progress” on reducing AMR, despite spending around £567 million on related programmes between 2020/21 and 2023/24.
