Zevtera approval shows efficacy and marks a new treatment option for bacterial infections including MRSA.
The FDA approved Zevtera (ceftobiprole medocaril sodium for injection), a novel antibiotic treating severe bacterial infections in adults and children. This significant advancement offers hope against Staphylococcus aureus bloodstream infections (SAB), including right-sided infective endocarditis, acute bacterial skin, and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP) in patients as young as 3 months.
Zevtera's approval is based on its performance in phase 3 randomized, controlled, double-blind trials. For SAB, a trial comparing Zevtera to daptomycin plus optional aztreonam showed a similar overall success rate at 70 days post-treatment. In ABSSSI, Zevtera was compared to vancomycin plus aztreonam, showing a high early clinical response rate. For CABP in adults, Zevtera was compared to ceftriaxone with optional linezolid, resulting in competitive clinical cure rates. Evidence from the adult CABP trial and a study in pediatric patients supported Zevtera’s approval for pediatric CABP.
Dr. Peter Kim, Director of the Division of Anti-Infectives at the FDA’s Center for Drug Evaluation and Research, emphasized the FDA's commitment to enhancing antibiotic options, stating, "The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Zevtera will provide an additional treatment option for a number of serious bacterial infections. The FDA will continue our important work in this area as part of our efforts to protect the public health.”1
Patients with a history of severe hypersensitivity to ceftobiprole, other cephalosporin antibiotics, or Zevtera’s components should avoid its use. The drug's labeling includes warnings about potential increased mortality in certain unapproved uses, risk of hypersensitivity reactions, seizures, and Clostridioides difficile associated diarrhea.
The approval for pediatric use in treating CABP is supported by adult trial evidence and a specific study involving 138 pediatric patients with pneumonia, ensuring Zevtera's applicability across a wide age range. Zevtera received Priority Review, Fast Track, and Qualified Infectious Disease Product designations for its indications, underscoring its potential to address unmet medical needs. This approval, granted to Basilea Pharmaceutica International Ltd., signifies a crucial step in managing serious bacterial infections.
Reference
1. FDA News Release. FDA Approves New Antibiotic for Three Different Uses. Published April 3, 2024. Accessed April 3, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses
