New Antibiotic Avycaz Wins FDA Approval

Disclosures

February 26, 2015

In another fast-track action to combat antibiotic resistance, the US Food and Drug Administration (FDA) yesterday approved the combination of ceftazidime-avibactam (CAZ-AVI; Avycaz, Forest Laboratories) to treat adults with complicated intra-abdominal or urinary tract infections, including kidney infections.

Ceftazidime is a third-generation cephalosporin that the FDA approved in 1985. Avibactam, a novel β-lactamase inhibitor, helps its chemical partner battle bacteria in the face of antibiotic resistance.

The new drug is indicated for patients who have limited or no alternative treatment options for the two kinds of infections. In addition, CAZ-AVI must be administered with metronidazole for intra-abdominal infections.

The FDA said it approved CAZ-AVI as a qualified infectious disease product, which entitled the drug to expedited review and 5 extra years of marketing exclusivity under a 2012 law designed to replenish the nation's inventory of antibiotics. CAZ-AVI is the fifth antibiotic okayed by the agency as a qualified infectious disease product.

"The FDA is committed to making therapies available to treat patients with unmet medical need," said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, in a news release. "It is important that the use of [CAZ-AVI] be reserved to situations when there are limited or no alternative antibacterial drugs for treating a patient's infection."

The FDA approved CAZ-AVI on the basis of two phase 2 trials of the combination drug, safety and efficacy data on ceftazidime by itself in the treatment of complicated intra-abdominal and urinary tract infections, and data on avibactam from in vitro studies and animal models of infection.

Vomiting, nausea, constipation, and anxiety are the new drug's most common adverse events. There also are risk factors that two categories of patients should know about, the agency said. Patients with poor kidney function have experienced seizures and other neurologic problems in addition to the drug not working as well. And some patients with penicillin allergies have had serious skin reactions and anaphylaxis.

An FDA advisory panel recommended approval of CAZ-AVI for complicated intra-abdominal and urinary tract infections in December 2014.

More information on yesterday's decision is available on the FDA website.

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