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FDA approves label update for cUTI treatment Avycaz
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The FDA has approved a supplemental New Drug application to update the label for Avycaz with data from two phase 3 trials demonstrating its efficacy in patients with complicated urinary tract infections, including pyelonephritis, caused by gram-negative bacteria, according to a press release.
“Gram-negative pathogens are among the most urgent antibiotic resistance threats and cause more than 40,000 resistant infections in the U.S. alone each year,” David Nicholson, PhD, chief R&D officer of Allergan, said in the release. “This new [supplemental New Drug application (sNDA)] approval for Avycaz is based on a large clinical database, comprising data from more than 1,300 patients with cUTI across phase 3 studies, including a number of patients with infections due to ceftazidime nonsusceptible (CAZ-NS) pathogens. It provides physicians with further clinical evidence that will assist them in making informed treatment decisions for their patients with cUTI, including those with difficult-to-treat pathogens.”
Avycaz (ceftazidime-avibactam, Allergan) was first approved in February 2015 as a treatment for complicated intra-abdominal infections (cIAIs), in combination with metronidazole, and for complicated urinary tract infections (cUTIs) caused by designated susceptible pathogens, including certain Enterobacteriaceae and Pseudomonas aeruginosa. Phase 3 data evaluating the drug combination in patients with cIAIs were added to the label in June.
The recent sNDA contained data from the RECAPTURE trial, involving 1,020 patients with cUTI, and the REPRISE trial, involving 305 patients with cUTIs caused by ceftazidime nonsusceptible gram-negative pathogens, according to the release. In the RECAPTURE trial, ceftazidime-avibactam was noninferior to doripenem in both of the trial’s primary endpoints, including the symptomatic response rate at day 5 (70.2% vs. 66.2%) and the combined patient-reported symptomatic response and microbiological cure at the test of cure visit in the microbiologically modified intent-to-treat (mMITT) population (71.2% vs. 64.5%). In the REPRISE trial, the combined clinical and microbiological cure rate at days 21 and 25 in the mMITT population was higher in patients who received ceftazidime-avibactam than those who received the best available therapy, which included meropenem, imipenem, doripenem and colistin (70.1% vs. 54%). In both trials, the clinical and microbiological cure rates in a subset of patients infected with CAZ-NS pathogens and those with pathogens producing extended spectrum beta-lactamase (ESBL) groups and AmpC beta-lactamases were similar to those of the overall population.
“The successful cumulative phase 3 cUTI studies further validate the initial FDA approval of Avycaz based on Phase 2 data,” Nicholson said in the release. “The inclusion of the REPRISE data in the label represents a significant advancement in the available data to support efficacy in cUTI patients infected with challenging pathogens, including certain ESBL and [Klebsiella pneumoniae carbapenamase]-producing Enterobacteriaceae, reinforcing Allergan’s leadership in responding to some of the most challenging infections facing our society today.”
Changes to the label will take effect immediately, according to an Allergan spokesperson. The drug combination is being jointly developed by Allergan, which holds commercialization rights in North America, and Pfizer, which holds rights to the drug combination in the rest of the world.
Disclosure: Nicholson is an employee of Allergan.