ceftobiprole medocaril (Zevtera)

following a resubmission

ceftobiprole (Zevtera®) is accepted for restricted use within NHS Scotland.

Indication under review: Ceftobiprole is indicated for the treatment of the following infections in adults:
• Hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP)
• Community-acquired pneumonia (CAP)
Consideration should be given to official guidance on the appropriate use of antibacterial agents.

SMC restriction: for use in the treatment of HAP (excluding VAP) when activity is required against suspected methicillin-resistant Staphylococcus aureus (MRSA) and Gram-negative pathogens (including Pseudomona aeruginosa, Escherichia coli and Klebsiella pneumoniae) and when combination treatment that includes vancomycin or teicoplanin is inappropriate or has not been tolerated, or when treatment modification is required, i.e. as an alternative to linezolid-based regimens.

In a randomised, double-blind phase III study of patients with HAP, the clinical cure rate  for empirical treatment with ceftobiprole was non-inferior to the rate associated with intravenous linezolid plus an anti-pseudomonal cephalosporin.