Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
The Food and Drug Administration (FDA) has expanded the approval of Zerbaxa (ceftolozane and tazobactam; Merck) to include treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients ≥18 years old. The treatment was initially approved in 2014 for complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis.
Zerbaxa is a combination of ceftolozane, a cephalosporin antibacterial, and tazobactam, a beta-lactamase inhibitor. Specifically, the treatment is indicated for HABP/VABP caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Serratia marcescens.
The approval was based on data from the phase 3 ASPECT-NP study conducted in 726 patients hospitalized with HABP/VABP. Patients were randomized to receive either Zerbaxa 3g intravenously (IV) every 8 hours or meropenem 1g IV every 8 hours for 8-14 days. The co-primary endpoints of the study were all-cause mortality at Day 28 and clinical cure, defined as complete resolution or significant improvement in signs and symptoms of the index infection at the test-of-cure (ToC) visit which occurred 7-14 days after the end of treatment.
Results showed that in the intent-to-treat population, Zerbaxa was found to be non-inferior to meropenem in all-cause mortality at Day 28 (24.0% vs 25.3%, respectively) and for clinical response at the ToC visit (54.4% vs 53.3%, respectively). Among HABP/VABP patients treated with Zerbaxa, the most common adverse reactions reported were increased hepatic transaminases, renal impairment/renal failure, and diarrhea.
Zerbaxa 1.5g for injection is supplied in single-dose vials containing ceftolozane 1g (equivalent to 1.147g of ceftolozane sulfate) and tazobactam 0.5g (equivalent to 0.537g of tazobactam sodium) per vial.
For more information visit merck.com.
This article originally appeared on MPR
