FDA approves label update for Avycaz (ceftazidime and avibactam) in combination with metronidazole for complicated intra-abdominal infections- Allergan

The FDA has approved the supplemental New Drug Application (sNDA) to update the label for Avycaz (ceftazidime and avibactam), from Allergan, with clinical data from a Phase III trial evaluating the safety and efficacy of Avycaz, in combination with metronidazole, for the treatment of complicated intra-abdominal infections (cIAI) caused by designated susceptible microorganisms. The approved label also contains data from a subset of patients in this trial with infections due to ceftazidime-nonsusceptible (CAZ-NS) pathogens, as well as a subset who had pathogens producing certain extended-spectrum beta-lactamases (ESBLs).

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 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.