Allergan announces FDA approval of sNDA for Avycaz

Label now includes Phase III clinical data evaluating the safety and efficacy of Avycaz (in combination with metronidazole) in patients with complicated intra-abdominal infections.

"Complicated intra-abdominal infections represent a major therapeutic challenge for physicians," said David Nicholson, Chief R&D Officer, Allergan. "Avycaz has been used in thousands of patients with these difficult-to-treat infections since it was first approved by the FDA in February 2015. The addition of these data to the label provides physicians with consistent evidence of the activity of Avycaz against some of the most challenging pathogens, including those for which we currently have limited treatment options."

"As a leader in anti-infectives, Allergan is committed to furthering the science needed to address the growing prevalence of these difficult-to-treat infections, helping physicians better understand the threat of challenging pathogens and equipping them with much needed treatments for their patients," Nicholson said.

This sNDA approval is based on results from a Phase III study that evaluated the efficacy and safety of Avycaz, in combination with metronidazole, for the treatment of patients with cIAI. The study showed that clinical cure rates at the Test of Cure (TOC) time point met the primary endpoint of statistical non-inferiority to meropenem. In a subset of patients with infections due to ceftazidime-resistant pathogens, as well as a subset who had pathogens that produced certain ESBLs, clinical cure rates for patients treated with Avycaz were similar to the overall results.

Avycaz has demonstrated in vitro activity against Enterobacteriaceae in the presence of some beta-lactamases and 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 over-express efflux pumps or have porin mutations.

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 susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa. In the treatment of cUTI, as only limited clinical safety and efficacy data for Avycaz are currently available, reserve Avycaz for use in patients with cUTI who have limited or no alternative treatment options. 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.