New Inj Combo Antibiotic Approved for Complicated UTI, IAI

New Inj Combo Antibiotic Approved for Complicated UTI, IAI
New Inj Combo Antibiotic Approved for Complicated UTI, IAI

Cubist announced that the Food and Drug Administration (FDA) has approved Zerbaxa (ceftolozane/tazobactam) Injection for the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by susceptible Gram-negative bacteria.

Zerbaxa combines ceftolozane, a cephalosporin antibiotic, and tazobactam, a beta-lactamase inhibitor. Ceftolozane inhibits cell wall biosynthesis and inhibits penicillin-binding proteins of P. aeruginosa and E. coli. Tazobactam is an irreversible inhibitor of some beta-lactamases and can bind covalently to some chromosomal and plasmid-mediated bacterial beta-lactamases.

RELATED: Ceftolozane/Tazobactam, a Promising Therapy for ESBL Infections

The FDA approval was based on data from a Phase 3 cUTI and a Phase 3 cIAI trial. In the cUTI trial, Zerbaxa achieved its primary endpoint of statistical non-inferiority vs. levofloxacin. The primary endpoint was a composite of microbiological eradication and clinical cure rate at 5-9 days after end of therapy. In the cIAI trial, Zerbaxa plus metronidazole, achieved the primary endpoint of statistical non-inferiority vs. meropenem. The primary endpoint was a clinical cure rate 24-32 days after treatment initiation.

Zerbaxa is the first antibiotic approved under the Generating Antibiotic Incentives Now (GAIN) Act to treat Gram-negative bacteria. It will be available as 1g/0.5g single-use vials in 10-count cartons.

For more information call (866) 793-2786 or visit Zerbaxa.com.

Loading links....