FDA approves Avycaz (ceftazidime and avibactam) for the treatment of patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.
The U.S. Food and Drug Administration (FDA) has approved Allergan plc’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.
The 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 the 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 dvelopment 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.”
The economic burden associated with HABP/VABP is significant. These infections are associated with increased healthcare costs, high morbidity and mortality, and lengthened hospital stays. HABP/VABP is currently the second most common type of nosocomial infection in the U.S., especially in the intensive care unit (ICU) of hospitals.2
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.
1 Examples of Antimicrobial (Drug) Resistance/Gram-Negative Bacteria, National Institute of Allergy and Infectious Diseases, https://www.niaid.nih.gov/research/gram-negative-bacteria.
2 Analytical Framework for Examining the Value of Antibacterial Products, U.S. Dept. of Health and Human Services, https://aspe.hhs.gov/system/files/pdf/76891/rpt_antibacterials.pdf.
(Source: Allergan plc)
Filed Under: Drug Discovery