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FDA Approves Antibacterial Drug Avycaz (Ceftazidime/Avibactam)

Fixed combination treats intra-abdominal and urinary-tract infections

Avycaz (ceftazidime/avibactam, Actavis), a new antibacterial drug product, has been approved by the FDA for the treatment of adults with complicated intra-abdominal infections (cIAIs), in combination with metronidazole, or with complicated urinary-tract infections (cUTIs), including pyelonephritis, who have limited or no alternative treatment options.

Specifically, Avycaz, in combination with metronidazole, is indicated for the treatment of cIAIs caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Providencia stuartii, Enterobacter cloacae, Klebsiella oxytoca and Pseudomonas aeruginosa.

Avycaz is also indicated for the treatment of cUTIs, including pyelonephritis, caused by the following susceptible microorganisms: E. coli, K. pneumoniae, Citrobacter koseri, E. cloacae, E. aerogenes, Citrobacter freundii, Proteus spp., and P. aeruginosa.

Avycaz is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin antibacterial drug, and avibactam, a new beta-lactamase inhibitor. It will be available in the second quarter of 2015.

Avycaz is the fifth approved antibacterial drug product designated as a qualified infectious disease product (QDIP). This designation is given to antibacterial products to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act.

As part of the QIDP designation, Avycaz was given “priority review” status, which allowed 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.

The FDA’s approval of Avycaz was based in part on efficacy and safety findings with ceftazidime in the treatment of cIAIs and cUTIs. The contribution of avibactam to Avycaz was based on data from in vitro studies and animal models of infection. Avycaz was studied in two phase II trials, one each in cIAIs and cUTIs.

Avycaz combines ceftazidime, a cephalosporin with in vitro activity against certain Gram-negative and Gram-positive bacteria, and avibactam, a non-beta-lactam beta-lactamase inhibitor that inactivates certain key beta-lactamases and protects ceftazidime from degradation by these beta-lactamases. The addition of avibactam to ceftazidime protects ceftazidime from breakdown by extended spectrum beta-lactamases, Klebsiella pneumoniae carbapenemase, and AmpC-producing pathogens.

The most common adverse effects associated with Avycaz include vomiting, nausea, constipation, and anxiety. Health care professionals should inform patients of these risks and should also advise them that decreased efficacy, seizures, and other neurologic events were seen in patients with renal impairment. Serious skin reactions and anaphylaxis may occur in patients with penicillin allergies.

Sources: FDA; February 26, 2015; and Actavis; February 25, 2015.


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