The Medicines and Healthcare products Regulatory Agency (MHRA)
has today (4 April 2024) approved the combined antibiotic
cefepime/enmetazobactam (Exblifep 2 g/0.5 g powder for
concentrate for solution for infusion) to treat adult patients
with complicated infections of the urinary tract (bladder and
kidneys) and certain types of pneumonia (infection of the lungs)
that occur during a hospital stay. The combined antibiotic can
also be used to treat bacteraemia (bacteria in the blood) due to,
or possibly due to, any of the infections listed above.
When infections in the urinary
tract or lungs
(pneumonia) develop resistance to traditional
antibiotics and complications arise, they can escalate to serious
and potentially life-threatening situations. Both urinary tract
infections and pneumonia can lead to bacteraemia, where bacteria
enter the bloodstream, potentially causing sepsis—a life-threatening
condition that occurs when the immune system overreacts to an
infection, damaging the body's own tissues and organs. In
England, approximately 130,000 episodes of patient bloodstream
infections occur each year, with an acute trust having
approximately 870 episodes per year on average, according to data
from NHS
England.
Cefepime/enmetazobactam has been approved in 55 days through the
MHRA's new International Recognition Procedure (IRP), which
supports expedited approvals for treatments in the UK market
thanks to international recognition. The IRP allows the MHRA to
accelerate the assessment of new medicines by considering the
expertise and decision-making of trusted regulatory partners in
the authorisation process. In coming to its decision, the MHRA
has recognised the recommendation from the European Medicines
Agency's Committee for Medicinal Products for Human Use (CHMP) on
26 January 2024.
Julian Beach, MHRA Interim Executive Director, Healthcare
Quality and Access, said:
Keeping patients safe and enabling their access to high quality,
safe and effective medical products are key priorities for us.
We're assured that the appropriate regulatory standards for the
approval of this medicine have been met.
As with all products, we will keep its safety under close review.
Cefepime/enmetazobactam is given to patients by a healthcare
professional as an infusion (drip) into a vein. The infusion is
given every 8 hours and lasts 2 hours (for complicated urinary
tract infection, including pyelonephritis) or 4 hours (for
hospital-acquired pneumonia, including ventilator-associated
pneumonia). The duration of treatment is 7 to 14 days depending
on the severity and location of the infection and the response to
treatment.
The active ingredients, cefepime and enmetazobactam, work in
different ways. Cefepime works by preventing certain bacteria
from making their own cell walls, thereby killing the bacteria.
Enmetazobactam helps cefepime work better by stopping certain
enzymes, called beta-lactamases, from breaking down cefepime
before it can kill the bacteria.
This approval is supported by evidence from a study involving
1041 adult patients where cefepime/enmetazobactam proved to be
more effective than another combined antibiotic (piperacillin and
tazobactam) in treating complicated urinary tract infections,
including acute pyelonephritis. After 7 to 14 days, about 79% of
cefepime/enmetazobactam-treated patients experienced a favourable
outcome (symptom resolution and bacterial eradication), compared
to 59% of those treated with piperacillin and tazobactam.
Another study involving 19 healthy adults evaluated the
distribution of the combined antibiotic in the body and showed
that the medicine can penetrate the lungs sufficiently to support
its use in the treatment of hospital-acquired pneumonia.
In a phase III study, the most common side effects of the
medicine (which may affect up to 1 in 10 people) include
high levels of alanine aminotransferase and aspartate
aminotransferase (liver enzymes), as well as diarrhoea and
phlebitis (inflammation of a vein) at the site of infusion.
Serious side effects with Exblifep include colitis (inflammation
of the colon) due to the bacteria Clostridioides difficile (which
may affect more than 1 in 1,000 people).
As with any medicine, the MHRA will keep the safety and
effectiveness of this medicine under close review. Any
suspected side effect from this medicine can be reported directly
to the MHRA 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.
Notes to editors
- The new marketing authorisation was granted on 4 April 2024
to Advanz Pharma Limited.
- More information can be found in the Summary of Product
Characteristics and Patient Information leaflets which will be
published on the MHRA
Products website within 7 days of approval.
- Applications under International
Recognition Procedure (IRP) can be received via the
MHRA website. Time horizons for authorisations are set at 60 to
110 days – considerably shorter than the current 150-day time
horizon for applications. To further streamline the IRP
application process, the MHRA launched an ‘Eligibility Checker'
tool on 20 November 2023.
- The Medicines and Healthcare products Regulatory Agency
(MHRA) is responsible for regulating all medicines and medical
devices in the UK by ensuring they work and are acceptably safe.
All our work is underpinned by robust and fact-based judgements
to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health
and Social Care.
