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.
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 hospitalsso 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, 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 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 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 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.
