Cefepime/enmetazobactam is administered intravenously for two hours to treat UTIs and four hours to treat pneumonia. Dosage is repeated every eight hours.
Treatment length varies from seven to 14 days, based on the infection’s severity and patient response.
The MHRA’s approval process for cefepime/enmetazobactam was expedited through the new International Recognition Procedure (IRP), taking only 55 days.
The IRP leverages the expertise of trusted international regulatory partners, in this case acknowledging the European Medicines Agency’s Committee for Medicinal Products for Human Use’s recommendation on 26 January 2024.
Clinical evidence supporting the approval includes a study in 1,041 adult patients in which the combined antibiotic demonstrated greater effectiveness than another comprising piperacillin and tazobactam in treating complicated UTIs.
Data from another study of 19 healthy adults showed that the antibiotic effectively penetrates the lungs, supporting its use against hospital-acquired pneumonia.
MHRA healthcare quality and access interim executive director Julian Beach stated: “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.”
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