Medicines Healthcare Products Regulatory Agency
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 sepsisa life-threatening condition that occurs when the immune system overreacts to an infection, damaging the bodys 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 MHRAs 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 Agencys 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.
Were 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 underInternational 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 anEligibility Checker toolon 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.
- For media enquiries, please contact the newscentre@mhra.gov.uk, or cal