The FDA has approved a new indication for ceftolozane and tazobactam (Zerbaxa, Merck & Co., Inc.) for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
Hospital-acquired and ventilator-associated bacterial pneumonia are serious infections and can lead to death in some patients. The infections, which occur in patients in hospitals or other health care facilities, can be caused by a variety of bacteria.
According to CDC data, HABP and VABP are the second most common type of hospital-acquired infection in the U.S., and are a major issue among patients in intensive care units.
The safety and efficacy of ceftolozane and tazobactam, which is administered via injection, was demonstrated in a multinational, double-blind study comparing Zerbaxa to another antibacterial drug in 726 adult patients with HABP/VABP. Mortality and cure rates proved similar between ceftolozane/tazobactam and the comparator drug.
The most common adverse reactions observed in the trial among patients treated with ceftolozane and tazobactam were elevated liver enzyme levels, renal impairment or failure, and diarrhea.
The FDA granted qualified infectious disease product and priority review designations to ceftolozane and tazobactam for the treatment of HABP/VABP. The drug combination was initially approved in 2014 to treat complicated intra-abdominal infections and complicated urinary tract infections.
Source: FDA, June 3, 2019