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FDA nod gives Allecra’s Exblifep headstart over competitor in complicated UTIs
Phase 3Drug ApprovalClinical ResultLicense out/in
The FDA approved Allecra Therapeutics’ Exblifep (cefepime/enmetazobactam) for the treatment of adults with complicated urinary tract infections (cUTIs), including acute pyelonephritis caused by susceptible gram-negative organisms. The approval came through nearly a month after the European Medicines Agency adopted a positive opinion on authorisation of the injectable antibiotic combination.
In a twist of fate, the FDA also issued a complete response letter on the same day to Venatorx Pharmaceuticals and Melinta Therapeutics for their combination of cefepime and taniborbactam in cUTI, asking them to submit additional chemistry, manufacturing, and controls data.
The approval was based on the Phase III ALLIUM study, involving 1034 patients with cUTI who were randomly assigned to receive an infusion of either Exblifep or piperacillin/tazobactam every 8 hours. The study’s primary endpoint was a composite of clinical cure and microbiological eradication at the test-of-cure visit.
The company noted that 79.1% of patients in the Exblifep group achieved the primary endpoint, significantly higher than the 58.9% in the piperacillin/tazobactam group. Exblifep was well tolerated and the safety profiles of the two were comparable.
Enmetazobactam, an extended-spectrum beta-lactamase inhibitor, was first discovered in 2008 by Orchid Pharma and subsequently out-licensed to Allecra for further development. While Allecra holds the marketing rights for Exblifep in the US, it has granted exclusive licenses to Advanz Pharma and Shanghai Haini to commercialise the combination in the EU and Greater China, respectively. Orchid stated that the combination is expected to hit the US market in the next couple of quarters.
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