Officials with the FDA have approved a new indication for ceftolozane and tazobactam combination (Zerbaxa, Merck) drug. The new approval indicates the medication for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients age 18 years and older.

Ceftolozane and tazobactam was initially approved by the FDA in 2014 for treating complicated intra-abdominal infections and for complicated urinary tract infections.

“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 prepared statement. “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.”

HABP/VABP occur in patients in hospitals or other health care facilities and can be caused by a variety of bacteria. According to data from the CDC, HABP and VABP are a significant issue in patients in the intensive care unit.

The safety and efficacy of the combination drug for the treatment of HABP/VABP, administered via injection, was demonstrated in a multinational, double-blind study that compared ceftolozane and tazobactam to another antibacterial drug in 726 adult patients hospitalized with HABP/VABP. The study showed that mortality and cure rates were similar between ceftolozane and tazobactam, and the comparator treatment.

The most common adverse reactions observed in the HABP/VABP trial among patients treated with ceftolozane and tazobactam were elevated liver enzyme levels, renal impairment or failure, and diarrhea, according to the FDA.

Ceftolozane and tazobactam had received the FDA’s Qualified Infectious Disease Product (QIDP) designation for the treatment of HABP/VABP. As part of QIDP designation, the drug’s marketing application for the HABP/VABP indication was granted Priority Review.


Reference

FDA approves new treatment for hospital-acquired and ventilator-associated bacterial pneumonia [news release]. Silver Spring, MD; June 3, 2019: FDA website. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-hospital-acquired-and-ventilator-associated-bacterial-pneumonia. Accessed June 3, 2019.