UK MHRA approves Advanz Pharma antibiotic for complex infections

2024-04-05

上市批准临床结果

UK MHRA approves Advanz Pharma antibiotic for complex infections

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来源: Pharmaceutical Technology

Cefepime/enmetazobactam is given intravenously every eight hours. Credit: Jacob Lund / Shutterstock.com.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Advanz Pharma’s combined antibiotic, cefepime/enmetazobactam, to treat complicated infections.

Marketed as Exblifep 2g/0.5g powder for concentrate for solution for infusion, the antibiotic treats adults suffering from complicated urinary tract infections (UTIs), certain kinds of pneumonia acquired during hospital stays, and bacteraemia that may arise from these conditions.

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.

Its active components are cefepime and enmetazobactam. Cefepime disrupts bacterial cell wall synthesis, leading to bacterial death. Enmetazobactam enhances cefepime’s efficacy by inhibiting beta-lactamases, enzymes that could degrade cefepime.

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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.

79% of subjects in the cefepime/enmetazobactam arm had a favourable outcome after seven to 14 days versus 59% for those in the piperacillin and tazobactam arm.

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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