FDA Panel Recommends Approval for New IV Antibiotic Product

Posted by The Evidence Blog on December 12, 2014

An investigational antibiotic product for hospitalized patients with limited treatment options is 1 step closer to the U.S. market. On December 5, 2014, a Food and Drug Administration (FDA) advisory panel recommended that ceftazidime-avibactam (CAZ-AVI; AstraZeneca and Actavis) be approved to treat 2 of 3 indications proposed in the pending New Drug Approval (NDA). FDA advisory panels provide nonbinding recommendations. A final regulatory decision is expected during the first quarter of 2015.

CAZ-AVI is a combination of ceftazidime, a currently marketed broad-spectrum antibiotic and avibactam, an investigational non-β-lactam, β-lactamase inhibitor (BLI). The FDA approved single-agent ceftazidime in 1985 under the trade name Fortaz. Avibactam (formerly NXL104) protects ceftazidime from degradation by β-lactamase enzymes. This helps maintain ceftazidime antibacterial activity against certain isolates of Enterobacteriaceae and Pseudomonas aeruginosa. CAZ-AVI is an intravenous (IV) drug. It is infused over 2 hours, 3 times daily, for up to 14 days.

The panel voted in favor of recommending CAZ-AVI when limited or no alternative treatments are available for the following indications:

  • Complicated intra-abdominal infections (cIAI) caused by gram-negative pathogens, when used in combination with metronidazole.
  • Complicated urinary tract infections (cUTI) caused by gram-negative pathogens, including acute pyelonephritis (AP).

CAZ-AVI is also proposed to treat aerobic gram-negative infections with limited or no alternative treatment options, including hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. However, the panel voted unanimously against recommending approval for this proposed indication.

The NDA is supported primarily by nonclinical research demonstrating avibactam’s efficacy to help ceftazidime sustain antibacterial activity against certain pathogens associated with multidrug resistance. Clinical evidence submitted includes 2 phase II clinical trials: 1 evaluating CAZ-AVI for treatment of cUTI3 and 1 evaluating CAZ-AVI to treat cIAI. The NDA also has evidence from several phase I studies and a literature review of ceftazidime alone in adults with cUTI.

Phase III trials of CAZ-AVI are in progress.

Topics: Hayes Blog

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