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Medical Professionals Reference (MPR)FDA Approves Antibiotic Zevtera to Treat Multiple Serious Infections

FDA Approval of Zevtera Enhances Antibiotic Arsenal Against Complex Bacterial Infections

The US Food and Drug Administration (FDA) has recently approved Zevtera® (ceftobiprole medocaril), expanding therapeutic options for a range of serious bacterial infections. This novel cephalosporin antibacterial demonstrates significant efficacy in treating conditions from Staphylococcus aureus bloodstream infections to community-acquired pneumonia across various age groups. The approval, grounded in robust clinical trials, marks a significant step in addressing gaps in current antibacterial treatments, particularly for infections resistant to conventional antibiotics.

Key Points:

  • FDA Approval: Zevtera has received FDA approval for three critical indications: Staphylococcus aureus bloodstream infections (bacteremia), acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP) for both adults and children aged 3 months and above.
  • Antibacterial Spectrum: It is effective against both gram-positive and gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-susceptible strains.
  • Clinical Trial Data: Approval was based on results from three phase 3 studies—ERADICATE, TARGET, and a CABP study—demonstrating Zevtera’s efficacy in achieving primary endpoints of treatment success.
    • ERADICATE Study: In treating complicated SAB, Zevtera showed noninferiority to daptomycin, achieving a primary success rate of 69.8% compared to 68.7% with daptomycin, alongside a microbiological eradication rate of 82.0%.
    • TARGET Study: Zevtera matched the efficacy of vancomycin plus aztreonam in ABSSSI, achieving early clinical response in 91.3% of patients and showing noninferior clinical success rates.
    • CABP Study Results: Demonstrated noninferior clinical cure rates compared to ceftriaxone, with or without linezolid, in treating community-acquired bacterial pneumonia.
  • Safety and Dosage: Supplied as a single-dose vial of lyophilized powder for reconstitution, indicating its user-friendly administration route.
  • Pediatric Approval: Significantly, the approval includes a pediatric indication, providing a new option for treating young patients with CABP.
  • Clinical Need: Addressing a substantial medical need, particularly for infections caused by resistant bacteria, Zevtera offers a promising alternative to existing antibiotics.

“We are very pleased that the FDA approved Zevtera for all 3 indications that were submitted with the NDA, including a pediatric labeling. This approval is a landmark for ceftobiprole and reflects its broad clinical utility.”
– Dr. Marc Engelhardt, Chief Medical Officer of Basilea

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