FDA
13th April 2017

FDA Panel Recommends Approval Of Actavis’ Ceftazidime-Avibactam

Ceftazidime-avibactam is an investigational antibiotic being developed to treat serious Gram-negative bacterial infections in hospitalized patients when limited or not treatment options are available.

FDA Panel Recommends Approval Of Actavis’ Ceftazidime-Avibactam

On December 5th, the Anti-Infective Drugs Advisory Committee (AIDAC) discussed new drug application (NDA) 206494 for ceftazidime-avibactam for injection, submitted by Cerexa Inc. (a subsidiary of Actavis), for the proposed indications of: Complicated Intra-abdominal Infections (cIAI), Complicated Urinary Tract Infections (cUTI), including Acute Pyelonephritis and Limited Use Indication: Aerobic Gram-negative Infections with Limited Treatment Options.

Ceftazidime-avibactam is an investigational antibiotic being developed to treat serious Gram-negative bacterial infections in hospitalized patients when limited or not treatment options are available. It consists of ceftazidime, a third-generation, antipseudomonal cephalosporin that is a well-established treatment for serious Gram-negative bacterial infections, and avibactam, a next generation, non-β lactam β-lactamase inhibitor.

Ceftazidime-avibactam inhibits a broad range of β- lactamases, including Class A (Extended-Spectrum β-Lactamases and Klebsiella pneumoniae carbapenemase), Class C (AmpC) and some class D enzymes produced by Gram-negative pathogens that are encountered in the hospital setting and involved in some of the most serious infections such as cIAI and cUTI.

The panel was asked four voting questions regarding the efficacy and safety of ceftazidime-avibactam, and found the scientific and clinical evidence submitted by Cerexa adequately demonstrated the safety and efficacy of ceftazidime-avibactam in the treatment of the proposed cIAI and cUTI indications. As such, panel members voted in favor of approval.

Panelists, however, raised concerns around labeling, particularly for patients with renal impairment. The committee voted not to recommend approval of the combination for hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP) and bacteremia.

“We are pleased with the committee’s positive recommendation for ceftazidime-avibactam. It reinforces our belief in the safety and efficacy of the compound and its potential to address significant unmet needs as a new treatment option for patients with serious and life-threatening infections,” said David Nicholson, senior vice president, Global Brands R&D, Actavis.

Actavis expects FDA action on its NDA for ceftazidime-avibactam during the first quarter of 2015. The FDA is not obligated to follow the advice of its panels, but normally does so.

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