FDA approves antibacterial for complicated UTI

March 2, 2015

The FDA has approved ceftazidime-avibactam (AVYCAZ) for two indications, including treatment of adults with complicated urinary tract infections who have limited or no alternative treatment options.

The FDA has approved ceftazidime-avibactam (AVYCAZ) for two indications, including treatment of adults with complicated urinary tract infections who have limited or no alternative treatment options.

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The approval includes treatment of pyelonephritis caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa.

Ceftazidime-avibactam was also approved for use in adult patients with complicated intra-abdominal infections (in combination with metronidazole).

The antibacterial received a priority review based on phase II data from manufacturer Actavis’ clinical development program and supporting in vitro data, and as such should be reserved for use in patients who have limited or no alternative treatment options, the company said.

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

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The new treatment 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, according to an Actavis news release. The addition of avibactam to ceftazidime protects ceftazidime from breakdown by extended spectrum beta-lactamases (ESBL), Klebsiella pneumoniae carbapenemase (KPC), and AmpC-producing pathogens.

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"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 David Nicholson of Actavis. "At Actavis, we are dedicated to helping bridge the gap in existing treatment options, and the development of new agents that may help address the urgent threat of these pathogens.

“We were very pleased to be working with the FDA to advance the approval of AVYCAZ as quickly as possible to make this important new treatment option available to physicians and patients at the earliest possible time."

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AVYCAZ was granted priority review and approval as a Qualified Infectious Disease Product (QDIP) in accordance with the Generating Antibiotics Incentives Now (GAIN) Act, which made it eligible for the FDA's fast-track program and a 5-year regulatory extension of exclusivity under the Hatch-Waxman Act.

The approval of ceftazidime-avibactam was supported in part by the FDA's previous findings of efficacy and safety for ceftazidime for the treatment of complicated UTI and complicated intra-abdominal infections. In addition, the contribution of avibactam to AVYCAZ was primarily established via in vitro data and animal models of infection. The agent was studied in two phase II, randomized, blinded, active-controlled, multicenter trials, one each in complicated  intra-abdominal infections and complicated UTI, including pyelonephritis. These phase II studies were not designed with any formal hypotheses for inferential testing against the active comparators.

The most common side effects include vomiting, nausea, constipation, and anxiety. Health care 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 (renal impairment), the FDA said. Serious skin reactions and anaphylaxis may occur in patients with penicillin allergies.

Ceftazidime-avibactam will be available in the second quarter of 2015.

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