US approves new antibiotic for life-threatening infections
The US Food and Drug Administration (FDA) has approved the use of a new antibiotic, ceftolozane plus tazobactam (Zerbaxa), for the treatment of adults with complicated intra-abdominal infections and complicated urinary tract infections.
The product approval was fast-tracked after it was given Qualified Infectious Disease Product status by the FDA in recognition of its potential to treat serious or life-threatening infections and as part of the agency’s drive to increase antibacterial and antibiotic product options for patients. It is the fourth new antibacterial to be given the go-ahead by the FDA this year.
Zerbaxa combines ceftolozane, a cephalosporin antibacterial drug, and tazobactam, a beta-lactamase inhibitor.
Drug manufacturer Cubist Pharmaceuticals described the approval of ceftolozane/tazobactam as an important day for patients.
“We are very pleased to arm physicians with Zerbaxa in the battle against Gram-negative bacteria, where few treatment options exist. The approval…demonstrates the agency’s commitment to make available new antibiotics that address this serious public health threat,” said Robert J Perez, the company’s president and chief operating officer.
Ceftolozane/tazobactam is currently unavailable in the UK and the European Union (EU).
The EU regulator, the European Medicines Agency (EMA), confirmed on 22 December 2014 that an application has been submitted for ceftolozane/tazobactam and is currently being assessed by its Committee for Medicinal Products for Human Use (CHMP).
The EMA said its scientific opinion will be made available at a future date.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20067484
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