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news.The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Merck's investigational antibiotic Zerbaxa (ceftolozane and tazobactam) to treat adults with complicated intra-abdominal infections, acute pyelonephritis and complicated urinary tract infections.
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Zerbaxa for injection (1.5g) is an antibacterial combination product for intravenous infusion consisting of the cephalosporin antibacterial drug ceftolozane sulfate and the beta-lactamase inhibitor tazobactam sodium.
The positive opinion will be reviewed by the European Commission and if confirmed, a centralized marketing authorization will be granted with unified labeling that is valid in the 28 countries that are members of the EU, as well as European Economic Area members, Iceland, Liechtenstein and Norway.
In the US, Zerbaxa is approved to treat adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa.
Zerbaxa used in combination with metronidazole is indicated for adults to treat complicated intra-abdominal infections (cIAI) caused by Gram-negative and Gram-positive microorganisms.
Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, and Streptococcus salivarius come under these microorganisms.
In order to reduce the development of drug-resistant bacteria and maintain the effectiveness of Zerbaxa and other antibacterial drugs, Zerbaxa should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.