The European Commission (EC) has approved the combination antibiotic ceftazidime/avibactam (Zavicefta, AstraZeneca) for the treatment of patients with serious Gram-negative bacterial infections requiring hospitalization, according to a company news release.
The combination drug is indicated for adults with complicated intra-abdominal and urinary tract infections and hospital-acquired pneumonia, as well as aerobic Gram-negative infections with limited treatment options.
EC approval follows a recommendation in April from the European Medicines Agency (EMA) to approve the ceftazidime/avibactam combination, as reported by Medscape Medical News.
"Zavicefta is an important addition to the arsenal of antibiotics in the global fight against antimicrobial resistance," Hans Sijbesma, managing director, AstraZeneca Antibiotics Business Unit, said in the news release. "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 program demonstrating the safety and efficacy of the ceftazidime/avibactam for the approved indications, according to the company.
Ceftazidime is a third-generation antipseudomonal cephalosporin, and avibactam is a first-in-class broad-spectrum beta-lactamase inhibitor. The beta-lactamase enzyme deactivates ceftazidime, so the inhibitor restores the antibiotic's power. Avibactam also counters enzymes produced by bacteria to deactivate the class of antibiotics called carbapenems.
The EC marketing authorization applies to all 28 EU member countries plus Iceland, Norway, and Liechtenstein.
Last year, the US Food and Drug Administration approved another combination of ceftazidime/avibactam (Avycaz, Allergan) to treat adults with complicated intra-abdominal or urinary tract infections.
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Cite this: European Commission Clears Antibiotic Zavicefta - Medscape - Jun 30, 2016.
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