Antibiotic Zevtera (Ceftobiprole medocaril)  approved by FDA for treatment of CABP, ABSSSI and SAB 

The broad-spectrum fifth-generation cephalosporin antibiotic, Zevtera (Ceftobiprole medocaril sodium Inj.) has been approved by FDA¹ for the treatment of three diseases viz.  

1. Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis;  

2. acute bacterial skin and skin structure infections (ABSSSI); and  

3. 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 pneumonia^6,7. 

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References:  

1. 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/ 

2. 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  

3. 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  

4. Scottish Medicine Consortium. Ceftobiprole medocaril (Zevtera). Available at https://www.scottishmedicines.org.uk/medicines-advice/ceftobiprole-medocaril-zevtera-resubmission-94314/  

5. 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 

6. Lupia T., et al 2022. Ceftobiprole Perspective: Current and Potential Future Indications. Antibiotics Volume 10 Issue 2. DOI: https://doi.org/10.3390/antibiotics10020170  

7. 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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