The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Allergan’s Avycaz (ceftazidime and avibactam) for priority review.
The sNDA filing seeks to expand the current indications for Avycaz to include hospital-acquired bacterial pneumonia/ventilator- associated bacterial pneumonia (HABP/VABP) in adult patients based on positive results from a Phase 3 clinical trial evaluating Avycaz for the treatment of patients with HABP/VABP, said Allergan in its press release.
The FDA granted priority review status to the application based on the previous Qualified Infectious Disease Product (QIDP) designation for Avycaz , and is expected to take action on the filing in the first quarter of 2018.
“The increasing prevalence of difficult-to-treat Gram negative pathogens causing serious bacterial infections, like HABP and VABP, has resulted in a critical need for new effective treatments to combat these threats,” said David Nicholson, Ph.D., Chief Research and Development Officer, Allergan.
Pending the sNDA approval, this will be the third indication for Avycaz, the company noted. Avycaz was first approved in Feburary 2015 in the U.S. for the treatment of adult patients with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa.