TUESDAY, June 11, 2019 -- Zerbaxa (ceftolozane and tazobactam) has been approved for a new indication to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients aged 18 years and older, the U.S. Food and Drug Administration announced yesterday.
In 2014, the FDA first approved Zerbaxa for treating complicated intra-abdominal infections and urinary tract infections. According to the manufacturer's prescribing information, Zerbaxa is administered in a recommended dosage regimen of a 1.5-g injection every eight hours by intravenous infusion for one hour. Treatment duration should be based on the infection site and severity and the patient's progress.
In a multinational, double-blind study of 726 patients hospitalized with HABP/VABP who were injected with Zerbaxa or another antibacterial drug, researchers found similar mortality and cure rates between the two drugs. The most commonly reported adverse reactions among patients treated with Zerbaxa included elevated liver enzyme levels, renal impairment or failure, and diarrhea.
The FDA notes that Zerbaxa should not be used in patients known to have serious hypersensitivity to the drug's components or to piperacillin/tazobactam or other antibacterial drugs in the beta lactam class.
Approval of Zerbaxa for this new indication was granted to Merck and Co.