ZEFTERA, A New Anti-MRSA Broad-spectrum Antibiotic Approved By Health Canada

Main Category: MRSA / Drug Resistance
Also Included In: Infectious Diseases / Bacteria / Viruses;  Regulatory Affairs / Drug Approvals
Article Date: 04 Sep 2008 - 1:00 PDT

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ZEFTERA has been approved by Health Canada for the treatment of complicated skin and skin structure infections (cSSSI), including non-limb-threatening diabetic foot infections without concomitant osteomyelitis.

This approval makes ZEFTERA the only approved antibiotic in its class (cephalosporin) to demonstrate efficacy against Methicillin-resistant Staphylococcus aureus (MRSA), a growing public health concern in both hospital and community settings.

ZEFTERA is specially designed to tightly bind to and inhibit targets in both gram-positive (including MRSA) and gram-negative bacteria.

MRSA infections are on the rise in many countries, particularly in Canada where the MRSA rate in hospital ICU's is approximately 22 per cent 1. Roughly 92 per cent of all MRSA infections occur in hospitalized patients in Canada; the remainder are acquired in the community.

The approval of ZEFTERA for the treatment of complicated skin and skin structure infections, including non-limb threatening diabetic foot infections without concomitant osteomyelitis, was based on results of two Phase III, double-blind, randomized, multi-centre, global trials involving 817 patients with cSSSI 2,3. Both studies demonstrated the non-inferiority of ceftobiprole to comparators. The first study demonstrated non-inferiority of ZEFTERA to vancomycin alone in patients with suspected or confirmed gram-positive cSSSI, and a second study demonstrated non-inferiority of ZEFTERA to a combination of vancomycin plus ceftazidime in patients with gram-positive and/or gram-negative infections.

The second Phase III trial included patients with non-limb threatening diabetic foot infections (mild, moderate or severe)3. Pathogens identified at baseline in this subpopulation included MSSA (38 per cent), MRSA (13 per cent), E. cloacae (9 per cent), and P. mirabilis (7 per cent). The results demonstrated the non-inferiority of ceftobiprole versus vancomycin plus ceftazidime in the treatment of diabetic foot infections.

In both studies, ZEFTERA was well tolerated. The most common treatment-emergent adverse reactions were nausea (9 per cent) taste disturbance (6 per cent), diarrhea (5 per cent) and vomiting (5 per cent).

Janssen-Ortho Inc. will market ZEFTERA in Canada. ZEFTERA is licensed from, and was co-developed with, Swiss-based Basilea Pharmaceutica Ltd, which will co-promote the drug in Canada.

References

1 The Canadian Antimicrobial Resistance Alliance. The Canadian Intensive Care Unit (CAN-ICU) Surveillance Study. 2007. Quebec.

2 Noel, G. J., Strauss, R. S., Amsler, K., Heep, M., Pypstra, R., and Solomkin, J. S. Results of a Double-Blind, Randomized Trial of Ceftobiprole Treatment of Complicated Skin and Skin Structure Infections Caused by Gram-Positive Bacteria (BAL00154). Antimicrob Agents Chemother 52[1], 37-44. 2008.

3 Noel, G. J., Bush, K., Bagchi, P., Ianus, J., and Strauss, R. S. A Randomized, Double-Blind Trial Comparing Ceftobiprole Medocaril with Vancomycin plus Ceftazidime for the Treatment of Patients with Complicated Skin and Skin-Structure Infections (BAL00414). Clin Infect Dis 46, 647-655. 2008.

Janssen-Ortho Inc.