The US Food and Drug Administration (FDA) has approved a new indication for the antibacterial Zerbaxa (Merck) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults 18 years and older.
Zerbaxa combines the cephalosporin ceftolozane and the beta-lactamase inhibitor tazobactam, and was initially approved in 2014 for complicated intra-abdominal infections and complicated urinary tract infections, as reported by Medscape Medical News.
HABP/VABP are the second most common type of hospital-acquired infections in the United States.
The safety and efficacy of Zerbaxa for the treatment of HABP/VABP, given by injection, was demonstrated in a multinational, double-blind study that compared Zerbaxa to another antibacterial drug in 726 adults hospitalized with HABP/VABP. In the study, mortality and cure rates were similar between Zerbaxa and the comparator treatment.
“A key global challenge we face as a public health agency is addressing the threat of antimicrobial-resistant infections,” FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, said in a news release.
HABP/VABP are “serious infections that can result in death in some patients. New therapies to treat these infections are important to meet patient needs because of increasing antimicrobial resistance. That’s why, among our other efforts to address antimicrobial resistance, we’re focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections,” said Abernethy.
The most common adverse reactions observed in the HABP/VABP trial among patients treated with Zerbaxa were elevated liver enzyme levels, renal impairment or failure, and diarrhea.
Zerbaxa should not be used in patients with known serious hypersensitivity to components of Zerbaxa, as well as hypersensitivity to piperacillin/tazobactam or other members of the beta-lactam class of antibacterial drugs, the FDA said.
Zerbaxa was given priority review and received FDA’s qualified infectious disease product (QIDP) designation. QIDP designation is given to antibacterial products that treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act.