Dr Nicola Rose: A new antibiotic is positive news – but it will take more to stay ahead of superbugs
Source: gov.uk (2025-10-12)

The MHRA’s Interim Executive Director of Science and Research writes in The British Medical Journal on the approval of the UK’s first new UTI antibiotic in nearly 30 years, and the wider challenge of tackling antibiotic resistance.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has recently approved gepotidacin (Blujepa), the UK’s first new type of antibiotic for urinary tract infections (UTIs) in nearly 30 years (https://www.gov.uk/government/news/mhra-approves-uks-first-new-type-of-antibiotic-for-urinary-tract-infections-in-nearly-30-years).

For the millions of women with recurring UTIs, this is life changing news. UTIs affect half of all women at some point in their lives and lead to millions of NHS appointments and prescriptions each year. For the estimated 1.6 million women in the UK with chronic UTIs, repeated infections mean days off work, cancelled plans, and constantly worrying about the next one.

The problem is that many UTIs no longer respond to the antibiotics we’ve relied on for decades: more than 90% of UTI causing bacteria are now resistant to at least one common medicine. The more we continue to use these, the more resistant the bacteria become. This results in infections that won’t clear up or that keep coming back.

And the consequences go far beyond UTIs. Without effective antibiotics we lose the ability to treat everyday infections, and we risk turning the clock back on modern medicine. Already, antibiotic resistant “superbugs” are estimated to cause 1.2 million deaths a year worldwide – and that number is rising.

That’s why the approval of gepotidacin matters. It works in a completely new way, blocking the enzymes that bacteria need in order to multiply. By giving doctors another option it takes the strain off older antibiotics, helping to slow the spread of resistance. In studies, gepotidacin was able to clear infections even when the bacteria no longer responded to standard antibiotics.

But one new antibiotic won’t be enough. What’s needed is progress on multiple fronts: faster access to promising medicines, better use of the ones we already have, and new scientific approaches altogether.

How the MHRA is helping tackle antibiotic resistance on multiple fronts

First, any promising treatments and tools need to reach patients quickly and safely. This applies not just to new antibiotics but also to better diagnostic tools – such as rapid DNA sequencing now being trialled in London hospitals (https://www.gov.uk/government/news/new-study-shows-mhra-collaboration-with-hospital-dna-sequencing-service-cuts-time-to-diagnose-infections) so that doctors can target infections more precisely – and to vaccines that can stop infections before they take hold. Developers can make use of the Innovative Licensing and Access Pathway (https://www.gov.uk/government/publications/innovative-licensing-and-access-pathway-ilap), a joint initiative with the MHRA, the NHS, and the National Institute for Health and Care Excellence to bring such advances to patients more quickly.

Second, we need to better understand how medicines perform in real life, not just in clinical trials. This means using real world data (https://www.gov.uk/government/news/mhra-highlights-remarkable-progress-and-launches-real-world-data-consultation-on-international-clinical-trials-day) from GPs, hospitals, pharmacies, and even sewage monitoring, to help track which antibiotics are losing effectiveness and where resistant bacteria are spreading. Expanding these systems with better coverage and linking data more effectively will give the whole health system the evidence needed for faster and smarter action against emerging threats.

Third, we must keep investing in science for the future. Research into the human microbiome – the trillions of microbes living on and inside us – suggests that “good” bacteria may sometimes succeed where antibiotics have failed. Then there’s bacteriophage therapy: using viruses that can target harmful bacteria and leave the rest of the body’s systems untouched, with regulatory guidance published this year (https://www.gov.uk/government/news/helping-bring-phage-medicines-to-uk-patients-guidance-for-industry) helping developers to advance this science safely.

Finally, antibiotic resistance is a global problem. Superbugs cross borders, and tackling them requires partners worldwide to work together more closely. This means sharing data between regulators, aligning regulatory requirements where possible, and supporting low and middle income countries in navigating clinical, regulatory, and adoption challenges. Initiatives such as the partnership between the Global AMR Innovation Fund (GAMRIF) and the MHRA (https://www.gov.uk/government/news/mhra-announces-dedicated-new-team-to-support-the-international-community-in-tackling-antimicrobial-resistance) are already exploring ways to provide practical, early stage guidance to innovators across all regions – helping new antibiotics, vaccines, and diagnostics to reach patients more efficiently and safely.

Supporting development

The UK already has strong expertise in infection research and should build on that. What’s needed now is sustained investment in new medicines, vaccines, and diagnostics – backed by regulation that is rigorous but also gives developers clarity and the confidence to invest. The MHRA’s role is to provide that clear scientific advisory and regulatory pathway, so that innovation can be translated safely into treatments patients can trust. Regulation helps to support development and adoption in areas of greatest need.

The challenge is huge, but so is the opportunity. To take on one of the biggest threats to modern medicine we need smarter use of existing medicines, faster development of new options, and stronger international collaboration to ensure that progress benefits everyone.

Regulators such as the MHRA can’t solve antimicrobial resistance alone, but we can help create the conditions for science and investment to thrive – so that the treatments we rely on still work when we need them most.

Notes to editor

This article was originally published in the British Medical Journal website (https://www.bmj.com/content/391/bmj.r2142).