The United States regulator has signed off on Allecra Therapeutics’ Exblifep (cefepime/enmatazobactam) as a treatment for cUTIs, including the severe kidney condition pyelonephritis, brought on by gram-negative bacteria.
SAINT-LOUIS, France & WEIL AM RHEIN, Germany--(BUSINESS WIRE)--Allecra Therapeutics (“Allecra”) announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for cefepime/enmetazobactam, an antibiotic combination of the fourth generation cephalosporin cefepime with the proprietary beta lactamase inhibitor, enmetazobactam, for the treatment of complicated urinary tract infections (cUTIs). Upon approval, the antibiotic combination will be marketed under the trademark name, EXBLIFEP®. EXBLIFEP® has been designed to combat anti-microbial resistance in gram-negative bacteria, especially resistance mediated by Extended Spectrum Beta Lactamases (or ESBLs). The NDA submission is supported by results from Allecra’s Phase 3 ALLIUM trial, which met criteria for non-inferiority and superiority compared to piperacillin/tazobactam in the primary composite outcome of clinical cure and microbiological eradication in patients with cUTIs.
CHICAGO--(BUSINESS WIRE)--Xentria Inc., a clinical-stage biotherapeutics company focused on developing therapeutics to address unmet clinical needs, and Meitheal Pharmaceuticals, Inc.1, today announced an exclusive multi-year licensing agreement to commercialize its lead candidate, and novel biologic, XTMAB-16 for pulmonary sarcoidosis in North America.
SAINT-LOUIS, France & WEIL AM RHEIN, Germany--(BUSINESS WIRE)--Allecra Therapeutics (“Allecra”) announced today that the final results from its Phase 3 ALLIUM trial investigating the combination of cefepime/enmetazobactam in patients with complicated urinary tract infections (cUTIs) have been published in the Journal of the American Medical Association (JAMA). The publication represents the first full analysis of the completed Phase 3 program, which showed that cefepime/enmetazobactam met criteria for non-inferiority and superiority compared to piperacillin/tazobactam in the primary outcome of clinical cure and microbiological eradication. Cefepime/enmetazobactam is a novel ?-lactam/?-lactamase inhibitor combination for the treatment of resistant gram-negative infections mediated by Extended Spectrum Beta-Lactamases (ESBLs). In addition to the robust data analysis, the publication highlights the need for novel antibacterial drugs to address antimicrobial resistance, which remains an urgent global public health threat causing an estimated 1.27 million deaths1 per year worldwide.