Priority Review Granted to Avycaz sNDA in cIAI

The sNDA submission included two new Phase 3 studies
The sNDA submission included two new Phase 3 studies

Allergan announced that the Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the supplemental New Drug Application (sNDA) for Avycaz (ceftazidime and avibactam) to add new clinical data to the current labeling.

The sNDA submission included new data from two Phase 3 studies evaluating the safety and efficacy of Avycaz, in combination with metronidazole, for the treatment of complicated intra-abdominal infections (cIAI), including those caused by ceftazidime-nonsusceptible (CAZ-NS) pathogens. The primary endpoint for both studies was to demonstrate non-inferiority to meropenem.

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Both studies met their primary endpoint showing that Avycaz was non-inferior to meropenem based on clinical cure rates at the Test of Cure (TOC) time point. Avycaz 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 pneumonia carbapenemase (KPCs), AmpC and certain oxacillinases (OXA). It 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 did not show activity against metallo-beta lactamase-producing organisms and may not be active against Gram-negative bacteria that overexpress efflux pumps or have porin mutations.

Avycaz was previously granted Qualified Infectious Disease Product (QIDP) designation by the FDA. Allergan expects the Agency to take action on the filing in the second quarter of 2016.

Avycaz consists of ceftazidime, a third-generation cephalosporin, and avibactam, a non-β lactam β-lactamase inhibitor. It is currently approved for the treatment of adults with cIAI, in combination with metronidazole, and complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginos.

For more information call (800) 433–8871 or visit Allergan.com.

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