Astrazeneca wins approval for new antibiotic in fight against drug resistance
AstraZeneca has won European regulatory approval for Zavicefta, a combination antibiotic developed in response to the increasingly urgent need for new drugs to treat serious infections that are becoming increasingly resistant to antibiotics.
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Zavicefta, a combination of ceftazidime-avibactam that has previously been known as CAZ AVI, has been granted marketing authorisation by the European Commission (EC) treatment of patients with serious Gram-negative bacterial infections requiring hospitalisation, such as complicated intra-abdominal infections and hospital-acquired pneumonia.
"Zaviceftais an important addition to the arsenal of antibiotics in the global fight against antimicrobial resistance," said Hans Sijbesma, managing director for AstraZeneca's antibiotics unit.
"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 approval, which applies to all 28 EU member countries plus Iceland, Norway and Liechtenstein, was based on data from three Phase III studies in complicated intra-abdominal infections; Phase II and III studies in complicated urinary tract infections; and data from a Phase I study for hospital acquired pneumonia.