FDA approval of Allecra therapeutics's novel Exblifep to overcome ESBL mediated AMR

By, Vaishnavi

The preferred choice of therapy for cUTI was piperacillin/Tazobactam. Due to increased resistance by the production of Extended Spectrum Beta Lactamase (ESBL), the first choice of drug was most compelling to be carbapenems. Carbapenems must be reserved for last as they are restricted antibiotics and help prevent the emergence of carbapenem resistant species.

FDA approval of exblifep with the generic Cefepime and enmetazobactam is a combination of fourth generation Cephalosporin with novel Beta-lactamase inhibitor, which is not hydrolysed by ESBL, but resistant to carbapenemase.

Based on phase III result of ALLIUM trial conducted by Allecra, the composite outcome was achieved in 73. 7% of patients in the test (Cefepime/ Enmetazobactam) drug group while only 51.5% in the standard (Piperacillin/Tazobactam) group. This depicted a non-inferiority and superiority to conventional standard therapy. The composite end point was based on the clinical cure and microbiological eradication of isolates in the patients.

This new combination of drug is approved for the treatment of Complicated Urinary tract infection (cUTI) , Hospital acquired Pneumonia (HAP), Community acquired pneumonia (CAP) caused by either Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, Enterobacter cloacae in patients with age of 18 years or older. Discovery of newer antibiotics in this combination, will help in reserving restricted antibiotics and also prevent the development of carbapenem resistant Enterobacterales.