FDA approves new antibacterial drug Avycaz

FDA has approved ceftazidime-avibactam (Avycaz, Actavis and Forest), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.  

Avycaz is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin antibacterial drug, and avibactam, a new beta-lactamase inhibitor.

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The contribution of avibactam to Avycaz was based on data from in-vitro studies and animal models of infection. Avycaz was studied in 2 phase 2 trials, one each in cIAI and cUTI. Both trials were not designed with any formal hypotheses for inferential testing against the active comparators.

“The FDA approval of Avycaz is an important step forward in enhancing our ability to respond to serious infections caused by difficult to treat Gram-negative pathogens,” said C. David Nicholson, PhD, executive vice president, Global Brands Research and Development, Actavis.

Nicholson

“The recent increase in the incidence of multidrug-resistant Gram-negative pathogens poses a significant threat to patients and places a tremendous strain on the US healthcare system and the increasing prevalence of Klebsiella pneumoniae Carbapenemase [KPC]-producing Enterobacteriaceae in particular, have become a major therapeutic challenge for physicians managing these infections,” Nicholson said.

In addition, Avycaz received a priority review based on Qualified Infectious Disease Product (QIDP) status. The review included phase 2 data from the company’s clinical development program and supporting in vitro data, and as such Avycaz should be reserved for use in patients who have limited or no alternative treatment options.

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To date, this accelerated review framework has only been used in select disease areas, like oncology, where patients are provided swift access to promising treatments when no suitable alternatives are available.

Avycaz is the fifth approved antibacterial drug product designated as QIDP.

As part of its QIDP designation, Avycaz was given priority review, which provides an expedited review of the drug’s application. The QIDP designation also qualifies Avycaz for an additional 5 years of marketing exclusivity to be added to the 5-year exclusivity period provided by the Food, Drug, and Cosmetic Act.

“Avycaz provides a new option for the treatment of serious infections caused by Gram-negative pathogens where there are currently very few or no effective options, and addresses important needs in the treatment of cUTI and cIAI,” Nicholson said.

The most common side effects include vomiting, nausea, constipation and anxiety. Healthcare professionals should inform patients of these risks and also advise that decreased efficacy, seizures and other neurologic events were seen in patients with poor kidney function. Serious skin reactions and anaphylaxis may occur in patients with penicillin allergies.

Cost has not yet been determined for Avycaz.