FDA has approved an sNDA for caftolozane/tezobactam for treatment of nosocomial pneumonia.
The US Food and Drug Administration has announced the approval of ceftolozano/tazbactam (ZERBAXA) for the treatment of nosocomial pneumonia.
In the United States ceftolozane/tazobactam (ZERBAXA) is indicated for the treatment of complicated urinary tract infections including pyelonephritis caused by certain susceptible Gram-negative microorganisms and also in combination with metronidazole for the treatment of complicated intra-abdominal infections. It was first approved by the FDA in 2014.
Ceftolozane/tazobactam is a combination treatment of an anti-pseudomonal cephalosporin, ceftolozane, and an extended-spectrum β-lactamase inhibitor, tazobactam.
"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.”
In February, the FDA accepted the sNDA of ceftolozane/tazobactam for priority review to treat patients with nosocomial pneumonia.The acceptance of the sNDA was based on the findings of the ASPECT-NP trial," said Amy Abernethy, MD, PhD, the FDA principal deputy commissioner.
The study used by the FDA for approval compared a new 3-gram dose regimen of ceftolozane/tazobactam with meropenem in patients who were mechanically ventilated with hospital-acquired/ventitlator-associated bacterial pneumonia (vHABP/VABP). A total of 726 participants were enrolled into the trial and were randomized 1:1 to 3gm ceftolozane/tazobactam or 1 g meropenem, both by intravenous infusion over 1 hour every 8 hours for 8 to 14 days, stratified by age and diagnosis.
The study’s primary endpoint was 28-day all-cause mortality (10% non-inferiority margin) and the secondary endpoint was clinical response at test-of-cure (7 to 14 days after end-of-therapy; 12.5% non-inferiority margin) in the intent-to-treat population.
Investigators noted that ceftolozane/tazobactam was found to be non-inferior to meropenem for the primary and key secondary endpoints. Mortality was reported to be the highest in meropenem-treated patients with vHABP.
“Zerbaxa had 2 indications already before the pneumonia study and many clinicians have argued that some of the most-resistant gram-negative pathogens they face are in pneumonia. And many clinicians were waiting patiently to see the pneumonia clinical trial results and I think many clinicians who treat patient with hospital and ventilator-associated pneumonia are going to be very pleased with the new treatment alternative that was approved today by the FDA," said Yoav Golan, MD, MS, Tufts Medical Center.