The US Food and Drug Administration has agreed to expand the label of Dublin, Ireland-based Allergan's Avycaz to include the treatment of complicated urinary tract infections (cUTI).
The decision is based on data from two Phase III clinical trials included in the submissions, which support the drug's use in cUTI, including pyelonephritis, caused by designated susceptible Gram-negative microorganisms.
In the RECAPTURE trial, Avycaz (ceftazidime and avibactam) was non-inferior to doripenem with regard to both primary endpoints (patient-reported symptomatic response at Day 5 and combined patient-reported symptomatic response and microbiological cure at the Test of Cure visit), while in the REPRISE study the treatment showed a higher combined clinical and microbiological cure rate versus best available therapy.
Both trials included a subset of patients with infections caused by pathogens producing certain ESBL groups and AmpC beta-lactamases in which the clinical and microbiological cure rates were similar to the overall results, the firm noted.
"Gram-negative pathogens are among the most urgent antibiotic resistance threats and cause more than 40,000 resistant infections in the US alone each year," said David Nicholson, chief R&D officer at Allergan.
"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 KPC-producing Enterobacteriaceae, reinforcing Allergan's leadership in responding to some of the most challenging infections facing our society today."
Ceftazidime and avibactam is being jointly developed with Pfizer; Allergan holds the rights to commercialise ceftazidime and avibactam in North America under the brand name Avycaz, while Pfizer holds the rights for the rest of the world under the brand name Zavicefta.
The therapy was first approved in the US in February 2015 for the treatment of adult patients with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and cUTI, including pyelonephritis, caused by designated susceptible pathogens, including certain Enterobacteriaceae and Pseudomonas aeruginosa.
In June 2016, the FDA cleared the addition of Phase III cIAI clinical data to the label that evaluated the safety and efficacy of Avycaz, in combination with metronidazole in cIAI patients, including subsets of patients with infections caused by CAZ-NS pathogens and pathogens producing certain ESBLs.