The broad-spectrum fifth-generation cephalosporin antibiotic, Zevtera (Ceftobiprole medocaril sodium Inj.) has been approved by FDA1 for the treatment of three diseases viz.
- Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis;
- acute bacterial skin and skin structure infections (ABSSSI); and
- community-acquired bacterial pneumonia (CABP).
This follows satisfactory phase 3 clinical trials results.
Ceftobiprole medocaril is approved in many European countries, as well as Canada for the treatment of hospital-acquired pneumonia (excluding ventilator-acquired pneumonia) and community-acquired pneumonia in adults2.
In the UK, Ceftobiprole medocaril is currently in phase III clinical trial3 however, it is accepted for restricted use within NHS Scotland4.
In EU, it appears in Union Register of refused medicinal products for human use5.
Ceftobiprole medocaril, a fifth-generation broad-spectrum cephalosporin effective against Gram-positive bacteria such as methicillin-resistant Staphylococcus aureus and penicillin-resistant Streptococcus pneumoniae, and against Gram-negative bacteria such as Pseudomonas aeruginosa. It has been found useful in the treating of community-acquired pneumonia and nosocomial pneumonia, except for ventilator-associated pneumonia6,7.
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References:
- FDA News release. FDA Approves New Antibiotic for Three Different Uses. Posted 03 April 2024. Available at https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses/
- Jame W., Basgut B., and Abdi A., 2024. Ceftobiprole mono-therapy versus combination or non-combination regimen of standard antibiotics for the treatment of complicated infections: A systematic review and meta-analysis. Diagnostic Microbiology and Infectious Disease. Available online 16 March 2024, 116263. DOI: https://doi.org/10.1016/j.diagmicrobio.2024.116263
- NIHR. Health Technology Briefing November 2022. Ceftobiprole medocaril for treating hospital-acquired pneumonia or community-acquired pneumonia requiring hospitalisation in children. Available at https://www.io.nihr.ac.uk/wp-content/uploads/2023/04/28893-Ceftobiprole-medocaril-for-pneumonia-V1.0-NOV2022-NONCONF.pdf
- Scottish Medicine Consortium. Ceftobiprole medocaril (Zevtera). Available at https://www.scottishmedicines.org.uk/medicines-advice/ceftobiprole-medocaril-zevtera-resubmission-94314/
- European Commission. Union Register of refused medicinal products for human use. Last updated on 21 February 2024. Available at https://ec.europa.eu/health/documents/community-register/html/ho10801.htm
- Lupia T., et al 2022. Ceftobiprole Perspective: Current and Potential Future Indications. Antibiotics Volume 10 Issue 2. DOI: https://doi.org/10.3390/antibiotics10020170
- Méndez1 R., Latorre A., and González-Jiménez P., 2022. Ceftobiprole medocaril. Rev Esp Quimioter. 2022; 35(Suppl 1): 25–27. Published online 2022 Apr 22. DOI: https://doi.org/10.37201/req/s01.05.2022
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 has been approved by FDA1 for the treatment of three diseases viz. Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis; acute bacterial skin and skin structure infections (ABSSSI); and community-acquired bacterial pneumonia (CABP).){kind=link}