The FDA gave providers another tool to manage treatment-resistant organisms with its recent approval of Avycaz. The drug is a fixed-combination of ceftazidime, a previously approved cephalosporin antibacterial agent, and avibactam, a new beta-lactamase inhibitor. Avycaz is approved to treat adults with complicated intra-abdominal infections and complicated urinary tract infections caused by gram-negative bacteria. Given that patients with these types of infections have limited or no treatment options, the FDA gave Avycaz a priority review and approved it on the basis of data from 2 phase II clinical trials, one each in complicated intra-abdominal infections and complicated urinary tract infections.
The accelerated review process is nothing new. Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, the FDA has the authority to designate antibacterial products to treat serious and life-threatening infections as Qualified Infectious Disease Products (QIDP). The QIDP designation entitles products to an expedited review of the drug’s application. In addition to Avycaz, 4 other antibacterial drug products have received the QIDP designation.
We recognize the need to get life-saving treatments to patients, especially when it comes to superbug infections for which we have few or no treatment options. Still, the evidence supporting the efficacy and safety of Avycaz is limited, with only 2 trials, and those phase II trials were not designed to compare Avycaz against other agents. Data from in vitro studies and animal models of infection also were considered. Thus, providers will need to weigh the risks versus the benefits.
In a press release announcing the approval, Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research (CDRH), noted that although the FDA is working to ensure that treatments be made available to patients with unmet medical needs, “Avycaz be reserved to situations when there are limited or no alternative antibacterial drugs for treating a patient's infection.”