AstraZeneca announced this week the positive decision for the new antibiotic CAZ AVI by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
The recommendation will be
reviewed by the European Commission (EC), which approves medications for use in
the European Union (EU).
CAZ AVI is an antibiotic developed to treat Gram-negative bacterial infections. It combines avibactam and ceftazidime. Many Gram-negative bacteria have developed a resistance to antibiotics, including P. aeurginosa, which is resistant to multiple drugs, and Enterobacteriaceae. Treatment options for these bacteria are limited. CHMP recommended CAZ AVI for intravenous use.
CAZ AVI was tested in clinical trials against complicated
intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI)
and pneumonia, including hospital acquired pneumonia (HAP) and ventilator
associated pneumonia (VAP). These studies included three Phase III studies on
cIAI, Phase II and III studies on cUTI and a Phase I study on HAP/VAP. The
CHMP's decision was based on the safety and efficiency of the CAZ AVI, which
resulted in positive trial results.
AstraZeneca and Allergan have jointly developed the antibiotic,
with Allergan holding North American rights and AstraZeneca holding the
remaining global rights.
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