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news.Irish pharmaceutical firm Actavis has launched Avycaz (ceftazidime-avibactam) in the US to treat adult patients with complicated intra-abdominal infections (cIAI) (in combination with metronidazole).
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Avycaz is a combination of ceftazidime, a cephalosporin, and avibactam, a non-beta-lactam beta-lactamase inhibitor.
The company said that currently only limited clinical safety and efficacy data for Avycaz is available and so the drug should be reserved for use in patients who have limited or no alternative treatment options.
Actavis Branded Pharma president William Meury said: "In light of the urgent medical need in the US for new antimicrobial treatments that address some of the most difficult to treat pathogens, Actavis increased the company’s manufacturing focus to ensure Avycaz would be available as soon as possible following FDA approval.
"We are proud to provide healthcare providers with this new therapeutic option that addresses serious Gram-negative infections for which there are few treatment options today."
The company said that the addition of avibactam to ceftazidime protects ceftazidime from breakdown by extended spectrum beta-lactamases (ESBL), Klebsiella pneumoniae carbapenemase (KPC) and AmpC producing pathogens.
The FDA approval of Avycaz was supported in part by the agency’s previous findings of efficacy and safety of ceftazidime for the treatment of cIAI and cUTI.
Avycaz is also approved by the US Food and Drug Administration (FDA) to treat complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa in patients 18 years of age and older.