The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Advanz Pharma’s combined antibiotic, Exblifep (cefepime/enmetazobactam), to treat adult patients with urinary tract infections (UTIs), certain pneumonia types acquired during hospital stays and bacteraemia.
Every year in England, approximately 130,000 patients are affected by bloodstream infections, which can result from infections in the urinary tract or pneumonia that develop resistance to traditional antibiotics.
This can lead to bacteraemia, when bacteria enter the bloodstream, which can potentially lead to sepsis, when the immune system overreacts to an infection, damaging the body’s own tissues and organs.
According to data from NHS England, every year, an acute trust has approximately 870 episodes on average of these serious complications.
Approved through the MHRA’s new International Recognition Procedure, the regulator accelerated the assessment of Exblifep after considering the recommendation from the European Medicines Agency’s human medicine’s committee in January.
The approval was supported by evidence from a study that involved 1,041 adult patients and showed that Exblifep was more effective than Pfizer’s combined antibiotic, Tazocin (piperacillin/tazobactam) , when treating complicated UTIs, including acute pyelonephritis.
Around 79% of patients treated with Exblifep experienced symptom resolution and bacterial eradication after seven to 14 days, compared to 59% of patients treated with Tazocin.
In addition, the combined antibiotic showed positive results in a study involving 19 healthy adults, which demonstrated that the medicine could penetrate the lungs to treat hospital-acquired pneumonia.
Julian Beach, interim executive director, healthcare quality and access, commented: “We’re assured that the appropriate regulatory standards for the approval of this medicine have been met” and the MHRA will keep the safety and effectiveness of Advanz Pharma’s Exblifep under close review.
Cefepime works to prevent certain bacteria from making their own cell walls and eliminating bacteria, while enmetazobactam stops certain enzymes known as beta-lactamases from breaking down cefepime before it can kill the bacteria.
In February, the US Food and Drug Administration approved Allecra Therapeutics’ Exblifep to treat complicated UTIs in the US, as established in Allecra and Advanz Pharma’s exclusive licence and supply agreement of the medicine in 2022.