EU approves Zavicefta (ceftazidime-avibactam) for treatment of serious Gram-negative bacterial infections requiring hospitalisation- AstraZeneca

AstraZeneca has announced that the European Commission (EC) has granted marketing authorisation for Zavicefta (ceftazidime-avibactam, previously known as CAZ AVI), a new combination antibiotic for the treatment of patients with serious Gram-negative bacterial infections requiring hospitalisation.

The approval includes intravenous use of Zavicefta for the treatment of adult patients suffering from complicated intra-abdominal infections (cIAI); Complicated urinary tract infections (cUTI), including pyelonephritis; hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP); and, the treatment of aerobic Gram-negative infections in adult patients who have limited treatment options.

The approval is based on data from an extensive clinical trial programme demonstrating the safety and efficacy of Zavicefta. The data include results from three Phase III studies in cIAI; Phase II and III studies in cUTI; and data from a Phase I study for HAP/VAP. An additional Phase III study evaluating the efficacy of Zavicefta in ceftazidime-resistant cUTI and cIAI, compared to the best available therapy, was also included in the submission.