Advanz Pharma receives positive CHMP opinion for Exblifep (cefepime/enmetazobactam) to treat complicated urinary tract infections,
Advanz Holdco Limited a UK headquartered global pharmaceutical company announced that the CHMP has adopted a positive opinion and recommended granting a marketing authorization for Exblifep, an antibiotic fixed-dose combination of cefepime and enmetazobactam.
The CHMP’s positive opinion will be referred to the European Commission, which will deliver a final decision in approximately two months.
Advanz Pharma and Allecra Therapeutics signed an exclusive license agreement in January 2022 under which Advanz Pharma gained the rights to further develop and commercialize Allecra’s proprietary antibiotic drug cefepime/enmetazobactam within the European Union, the United Kingdom, Switzerland, and Norway.
Exblifep demonstrated significant superiority in the primary composite endpoint of clinical cure and microbiological eradication in a phase III clinical trial over piperacillin/tazobactam in patients with complicated urinary tract infections caused by gram negative bacteria. The positive opinion includes intravenous use of Exblifep for the treatment of adults patients with complicated urinary tract infections (cUTI), including pyelonephritis; hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP); and the treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed.
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