Allergan: FDA Approves SNDA For AVYCAZ To Include Phase III Data - Quick Facts

(RTTNews) - Allergan plc (AGN) announced the FDA has approved the company's sNDA to update the label for AVYCAZ (ceftazidime and avibactam) with clinical data from two Phase 3 trials supporting the indication to treat patients with complicated urinary tract infections, including pyelonephritis, caused by designated susceptible Gram-negative microorganisms.

David Nicholson, Chief R&D Officer, Allergan said: "This new sNDA approval for AVYCAZ is based on a large clinical database, comprising data from more than 1,300 patients with cUTI across Phase 3 studies. The successful cumulative Phase 3 cUTI studies further validate the initial FDA approval of AVYCAZ based on Phase 2 data. The inclusion of the REPRISE data in the label represents a significant advancement in the available data to support efficacy in cUTI patients infected with challenging pathogens, including certain ESBL and KPC-producing Enterobacteriaceae, reinforcing Allergan's leadership in responding to some of the most challenging infections facing our society today."