EC approves Zavicefta for severe bacterial infections

The European Commission (EC) has approved Zavicefta (ceftazidime-avibactam) for use in the European Union (EU), AstraZeneca announced this week. 

The combination antibiotic can be used to treat hospitalized patients suffering from gram-negative bacterial infections.

The medication was developed to treat serious infections caused by drug resistant bacterium, including P. aeruginosa, Enterobacteraceae and gram-negative pathogens. Zavicefta is now approved to treat patients with complicated intra-abdominal infections (cIA), complicated urinary tract infections (cUTI) and gram-negative infections. Hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) are also among the infections approved for intravenous treatment with Zavicefta.

“Zavicefta is an important addition to the arsenal of antibiotics in the global fight against antimicrobial resistance," AstraZeneca Antibiotics Business Unit Managing Director Hans Sijbesma said. "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 EC's marketing authorization was based on results from three cIAI Phase III trials, cURI Phase II and III trials and an HAP/VAP Phase I trial. Zavicefta was also evaluated in a Phase III trial for ceftazidime-resistant cUTI and cIAI.