FDA: New Option for Hospital-Acquired Bacterial Pneumonia
The US Food and Drug Administration has approved a new treatment for adults with hospital-acquired and ventilator-associated bacterial pneumonia.
The drug, Zerbaxa (ceftolozane and tazobactam), was originally approved in 2014 for complicated intra-abdominal infections and complicated urinary tract infections.
This new indication comes after a multinational, double-blind study compared Zerbaxa as an injection with another antibacterial drug in 726 adult patients with hospital-acquired and ventilator-associated bacterial pneumonia. Results showed that the safety and efficacy rates were similar between the 2 drugs.
The most common adverse events were elevated liver enzyme levels, renal impairment or failure, and diarrhea.
“A key global challenge we face as a public health agency is addressing the threat of antimicrobial-resistant infections,” said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, in a press release.
“Hospital-acquired and ventilator-associated bacterial pneumonia 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.”
FDA approves new treatment for hospital-acquired and ventilator-associated bacterial pneumonia [press release]. Silver Spring, MD; US Food and Drug Administration; June 3, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-hospital-acquired-and-ventilator-associated-bacterial-pneumonia?utm_campaign=060319_PR_FDA%20approves%20treatment%20for%20hospital-acquired%20and%20ventilator-associated%20bacterial%20pneumonia. Accessed June 4, 2019.