Allergan: Positive Phase III Studies Further Support AVYCAZ - Quick Facts

(RTTNews) - Allergan plc (AGN) announced positive topline results from RECAPTURE 1 and 2, the Phase III studies evaluating the antibiotic AVYCAZ (ceftazidime-avibactam) as a treatment for adult hospitalized patients with complicated urinary tract infections, including pyelonephritis. In the studies, AVYCAZ met the objective of statistical non-inferiority compared to doripenem for both the EMA primary and FDA co-primary endpoints.

Ceftazidime-avibactam was approved by the FDA as AVYCAZ in February 2015 for the treatment of complicated urinary tract infections including pyelonephritis and complicated intra-abdominal infections, in combination with metronidazole, caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa for patients 18 years of age and older.

Allergan plans to submit the data as a supplemental New Drug Application to the FDA by the end of 2015. The company said the results further support the use of AVYCAZ as a treatment option for patients with complicated urinary tract infections.

Ceftazidime-avibactam is being jointly developed by Allergan with AstraZeneca. Allergan holds the rights to commercialize ceftazidime-avibactam in North America, while AstraZeneca holds the rights to commercialize ceftazidime-avibactam in the rest of the world.