The FDA grants Allegran’s sNDA for AVYCAZ priority review

Allegran announced this week that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for AVYCAZ and has granted the sNDA priority review status.

Allegran’s filing for AVYCAZ will add new information to the drug’s label based on data that was collected during two Phase 3 trials.

The trials were focused on the safety and efficiency of AVYCAZ, which was combined with metronidazole, and used to treat complicated intra-abdominal infections (cIAI). The studies also included patients who had contracted infections due to ceftazidime-nonsusceptible (CAZ-NS) pathogens. AVYCAZ was granted priority review by the FDA because of its prior Qualified Infectious Disease Product (QIDP) designation.

The FDA first approved ANYCAZ in February of last year to treat adults with cIAI by being combined with metronidazole. The drug was also approved for patients with complicated urinary tract infections (cUTI). The approval was based on data from a Phase 2 trial that resulted in the label specifying that ANYCAZ be used only in patients with cIAI and cUTI that have limited or no options for treatment.

Allegran expects a decision on AVYCAZ by the FDA in the second quarter of 2016.