The European Commission (EC) has granted marketing authorisation for AstraZeneca’s new combination antibiotic Zavicefta.
Zavicefta (ceftazidime-avibactam, previously known as CAZ AVI), has been developed for the treatment of patients with serious Gram-negative bacterial infections that require hospitalisation.
The EC 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)
- the treatment of aerobic Gram-negative infections in adult patients who have limited treatment options.
There is currently an urgent need for new antibiotics to tackle serious infections that are increasingly becoming resistant to existing drugs. These infections include multi-drug resistant P. aeruginosa, carbapenem-resistant Gram-negative pathogens, and ESBL-producing Enterobacteriaceae.
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 Zavicefta.
The EC marketing authorisation applies to all 28 EU member countries plus Iceland, Norway and Liechtenstein.