Allergan Files SNDA To Expand AVYCAZ Label - Quick Facts

(RTTNews) - Allergan plc (AGN) announced the U.S. FDA has accepted for filing the company's supplemental New Drug Application for AVYCAZ (ceftazidime and avibactam). The filing will add important new clinical data to the current label from two Phase 3 trials evaluating the safety and efficacy of AVYCAZ, in combination with metronidazole, for the treatment of complicated intra-abdominal infections, including patients with infections due to ceftazidime-nonsusceptible pathogens. Allergan expects the Agency to take action on the filing in the second quarter of 2016.

AVYCAZ was first approved in the U.S. in February 2015 for the treatment of adult patients with complicated intra-abdominal infections, in combination with metronidazole, and complicated urinary tract infections, including pyelonephritis, caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa. The original approval was based on Phase 2 data and supporting in vitro data. The current labeling denotes AVYCAZ should be reserved for use in cIAI and cUTI patients who have limited or no alternative treatment options.