AstraZeneca’s new antibiotic Zavicefta approved in the EU
Posted: 28 June 2016 | | 1 comment
The EC has granted marketing authorisation for Zavicefta for the treatment of patients with serious Gram-negative bacterial infections…
The European Commission (EC) has granted marketing authorisation for AstraZeneca’s combination antibiotic Zavicefta (ceftazidime-avibactam) 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.
Zavicefta has been developed in response to the urgent need for new antibiotics to treat serious infections that are becoming increasingly resistant, such as multi-drug resistant P. aeruginosa, carbapenem-resistant Gram-negative pathogens, and ESBL-producing Enterobacteriaceae.
Adding to the arsenal of antibiotics
Commenting on the approval, Hans Sijbesma, Managing Director, AstraZeneca Antibiotics Business Unit, said: “Zavicefta is an important addition to the arsenal of antibiotics in the global fight against antimicrobial resistance. Effective treatment options are rapidly running out for serious Gram-negative infections. Zavicefta helps bridge that gap and allows a broad population of patients across Europe to benefit from this new medicine.”
The approval is based on data from an extensive clinical trial programme demonstrating the safety and efficacy of the antibiotic. 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.