DUBLIN, Feb. 1, 2018 /PRNewswire/ — Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Allergan’s supplemental New Drug Application (sNDA) to expand the approved use of AVYCAZ® (ceftazidime and avibactam) to include the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by the following susceptible Gram-negative microorganisms: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae in patients 18 years of age or older. This expanded use is based on positive results from a pivotal Phase 3 study evaluating the efficacy and safety of AVYCAZ for the treatment of adult patients with HABP/VABP. The sNDA received priority review from FDA based on the Qualified Infectious Disease Product (QIDP) designation for the HABP/VABP indication.
Certain types of Gram-negative bacteria have become increasingly resistant to available antibiotics, resulting in increased illness and death as well as contributing to escalating healthcare costs.1 New strategies to fight these challenging infections have been long-awaited by the medical community.
“Healthcare providers in the U.S. have not had access to a new treatment option for patients with HABP/VABP due to Gram-negative bacteria in over 15 years,” said David Nicholson, Ph.D., Chief Research and Development Officer, Allergan. “Gram-negative pathogens are some of the most pressing antibiotic resistance threats and cause more than 40,000 resistant infections in the U.S. annually. Today’s action by the FDA is further evidence of Allergan’s commitment to improving outcomes and meeting critical needs in patients with life-threatening infectious diseases.”
This is the third therapeutic indication for AVYCAZ. AVYCAZ was first approved in February 2015 in the U.S. for the treatment of adult patients with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and in 2017 for complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible Gram-negative bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa.
“Clinical efficacy along with patient safety are critical priorities to clinicians managing serious Gram-negative bacterial infections. We are thrilled to have a new option available to treat HABP/VABP, some of the most challenging Gram-negative infections in the hospital setting,” said Jose Vazquez, M.D., FIDSA, Division Chief and Professor of Medicine Infectious Diseases, Medical College of Georgia/Augusta University, Augusta, GA.
Data Supporting the Approval
A total of 870 hospitalized adult patients with HABP or VABP were randomized and received trial medications in a pivotal Phase