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.
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