FDA accepts and grants Priority Review for Avycaz sNDA

Application seeks to expand Avycaz label to include Phase III clinical data for the treatment of complicated intra-abdominal infections , in combination with metronidazole.

Avycaz was first approved in the US in February 2015 for the treatment of adult patients with cIAI, in combination with metronidazole, and complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa. This original approval was based on Phase II data from the company's clinical development program and supporting in vitro data, and as a result, the current labeling denotes Avycaz should be reserved for use in cIAI and cUTI patients who have limited or no alternative treatment options.

"Since its approval, Avycaz has provided physicians with a treatment option to address complicated intra-abdominal infections caused by certain Gram-negative pathogens for which physicians currently have limited or no options," said David Nicholson, President and Executive Vice President, Global R&D, Allergan. "This acceptance is encouraging, as the inclusion of full Phase III clinical data to the label further demonstrates the safety and efficacy of Avycaz in difficult-to-treat infections and provides physicians further validation of the drug's spectrum of activity against pathogens of greatest concern."

"We look forward to working with the FDA in the coming months to add these data to the Avycaz label. We are committed to the ongoing development of our anti-infective portfolio to help the healthcare community respond effectively to serious infections," Nicholson said.

The application included results from two Phase III studies, which evaluated the efficacy and safety of Avycaz, in combination with metronidazole, for the treatment of patients with cIAI, including patients with infections due to Gram-negative pathogens that met pre-specified criteria for pathogens resistant to ceftazidime alone but susceptible to Avycaz. In these studies, clinical cure rates at the Test of Cure (TOC) time point met the primary endpoint of statistical non-inferiority to meropenem. Avycaz has demonstrated in vitro activity against Enterobacteriaceae in the presence of some beta-lactamases and extended-spectrum beta-lactamases (ESBLs) of the following groups: TEM, SHV, CTX-M, Klebsiella pneumoniae carbapenemase (KPCs), AmpC and certain oxacillinases (OXA). Avycaz also demonstrated in vitro activity against Pseudomonas aeruginosa in the presence of some AmpC beta-lactamases, and certain strains lacking outer membrane porin (OprD). Avycaz is not active against bacteria that produce metallo-beta lactamases and may not have activity against Gram-negative bacteria that overexpress efflux pumps or have porin mutations.

Phase III studies evaluating the safety and efficacy of Avycaz for the treatment of cUTI have been completed and the data is being analysed for submission later this year.

Ceftazidime and avibactam is being jointly developed with AstraZeneca. Allergan holds the rights to commercialize ceftazidime and avibactam in North America, while AstraZeneca holds the rights to commercialize the combination in the rest of the world.