FDA Grants Priority Review to Label Update for Antibacterial Drug

The FDA has accepted and designated priority review to Allergan’s supplemental new drug application for ceftazidime and avibactam (Avycaz).

Allergan hopes to expand the label to include new data from 2 phase 3 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 pathogens.

In the trial, Avycaz met the primary endpoint of statistical non-inferiority to meropenem.

Allergan expects the FDA to take action on the application in the second quarter of 2016.

Avycaz was approved in February 2015 for treating adults’ cIAI, in combination with metronidazole, and complicated urinary tract infections, including pyelonephritis. This original indication was approved based on phase 2 data and from supporting in vitro data.

“As a result, the current labeling denotes Avycaz should be reserved for use in cIAI and complicated urinary tract infection patients who have limited or no alternative treatment options,” Allergan said in a press release.

"This acceptance is encouraging, as the inclusion of full phase 3 clinical data to the label further demonstrates the safety and efficacy of Avycaz in difficult-to-treat infections and provides physicians further validation of the drug's spectrum of activity against pathogens of greatest concern," added David Nicholson, PhD, president and executive vice president, Global R&D, Allergan, in a press release.

The most common adverse effects of Avycaz include vomiting, nausea, and constipation.