29 April 2016
AstraZeneca has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends the approval of a new antibiotic, CAZ AVI 2g/0.5g powder.
CAZ AVI is being developed for treating a broad range of Gram-negative bacterial infections that are increasingly resistant to antibiotics. These include multi-drug resistant P. aeruginosa, ESBL-producing Enterobacteriaceae, and carbapenem-resistant Gram-negative pathogens. Increasing antibiotic resistance in Gram-negative bacteria is a growing public health concern due to the limited new treatment options for these serious infections. Gram-negative bacteria are responsible for two thirds of the annually reported 25,000 deaths in Europe, resulting from antimicrobial resistance.
The recommendation is for intravenous use for treating adult patients with complicated intra-abdominal infection (cIAI), hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), and complicated urinary tract infection (cUTI) including pyelonephritis. It is also recommended by the CHMP that CAZ AVI needs to be indicated for the treatment of infections caused by aerobic Gram-negative organisms in adult patients who have limited treatment options.