FDA accepts supplemental application (sNDA) for Avycaz (ceftazidime and avibactam) to treat cIAI including infections due to ceftazidime-nonsusceptible (CAZ-NS) pathogens.- Allergan

Allergan plc has announced the FDA has accepted for filing the company's supplemental New Drug Application (sNDA) for AvyCaz (ceftazidime and avibactam). This filing will add important new clinical data to the current label from two Phase III trials evaluating the safety and efficacy of AvyCaz, in combination with metronidazole, for the treatment of complicated intra-abdominal infections (cIAI), including patients with infections due to ceftazidime-nonsusceptible (CAZ-NS) pathogens. The FDA granted priority review status to this application based on the previous Qualified Infectious Disease Product (QIDP) designation for Avycaz. 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 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.