The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of CAZ AVI 2g/0.5g formulation for the treatment of bacterial infections, including those responsible for hospital-acquired pneumonia.
CAZ-AVI (Ceftazidime/avibactam) is a fixed-dose combination drug containing an antibiotic — 3rd generation cephalosporin ceftazidime — and a new non-β-lactam β-lactamase inhibitor, avibactam, being jointly developed by AstraZeneca and Allergan for the treatment of serious gram-negative bacterial infections that are resistant to antibiotics.
Resistance rates are increasing among several problematic gram-negative pathogens that are often responsible for serious nosocomial infections, including Acinetobacter spp., Pseudomonas aeruginosa, and Enterobacteriaceae. The presence of multiresistant strains of these organisms has been associated with prolonged hospital stays, higher healthcare costs, and increased mortality, particularly when initial antibiotic therapy does not provide coverage of the causative pathogen.
In the case of Europe, gram-negative bacteria account for two-thirds of the 25,000 deaths per year caused by antimicrobial resistance.
CHMP recommends CAZ AVI as an intravenous treatment for adults with hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), adults with complicated intra-abdominal infection (cIAI), adults with complicated urinary tract infection (cUTI), as well as for infections caused by aerobic Gram-negative organisms in adults with reduced treatment alternatives.
The drug was approved by the U.S. Food and Drug Administration (FDA) in February 2015 to treat cIAI adults in combination with metronidazole, and for adults with cUTI, including kidney infections (pyelonephritis), who have limited or no alternative treatment options.
According to a press release, the positive CHMP opinion was based on the results of a clinical trial program showing CAZ AVI’s efficacy and safety. The program consisted of three Phase 3 clinical trials in patients with cIAI; Phase 2 and 3 clinical trials in patients with cUTI; and a Phase 1 trial in patients with HAP/VAP. An additional Phase 3 trial, which assessed the efficacy of CAZ AVI in ceftazidime-resistant cUTI and cIAI paralleled to the best existing treatment option, was also included for the CHMP consideration.
The European Commission will now review the CHMP recommendation, with a final decision expected shortly.
AstraZeneca retains global commercial rights to ceftazidime-avibactam, except in North America, where Allergan holds the exclusive rights.
HAP refers to any pneumonia contracted by a patient in a hospital at least 48–72 hours after being admitted. It is usually caused by a bacterial infection, rather than a virus. HAP is the second most common nosocomial infection (after urinary tract infections), and accounts for 15 percent to 20 percent of the total. It is the most common cause of death among nosocomial infections, and the primary cause of death in intensive care units. HAP typically lengthens a hospital stay by one or two weeks.
VAP is a type of lung infection that occurs in people who are on breathing machines in hospitals. As such, they are seriously ill and in an intensive care unit.