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FDA Approves New Antibiotic for Three Different Uses
Originally published: 04 April 2024
Source: FDA Press Release
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDN008
Category: Paediatrics & Neonatology
Crossreference: Infectious Diseases, Antimicrobials
Category tags: Antimicrobials, Antibiotics, CAP, pneumonia, URTI, LRTI
| Product Category | Product Name | Company | Status |
|---|---|---|---|
| Completed |
The U.S. Food and Drug Administration has approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of Staphylococcus aureus bloodstream infections (SAB), acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP) in adults and pediatric patients aged three months to less than 18 years with CABP.
Zevtera’s efficacy in treating SAB was assessed in a randomized, controlled, double-blind trial involving 390 subjects. A total of 69.8% of subjects who received Zevtera achieved overall success compared to 68.7% of subjects who received the comparator.
For ABSSSI, Zevtera's efficacy was evaluated in a multinational trial with 679 subjects. Of those who received Zevtera, 91.3% achieved an early clinical response within 48-72 hours compared to 88.1% of subjects who received the comparator.
In a double-blind, multicenter trial involving 638 adults with CABP, 76.4% of subjects who received Zevtera achieved clinical cure compared to 79.3% of subjects who received the comparator.
Evidence from trials in adults and pediatric subjects aged three months to less than 18 years with pneumonia supported the approval for pediatric patients with CABP.
Common side effects of Zevtera for adults with SAB include anaemia, nausea, hypokalemia, vomiting, diarrhoea, increased hepatic enzymes, increased blood creatinine, high blood pressure, leukopenia, fever, abdominal pain, fungal infection, headache, and dyspnea.
Clinical Trials & Supporting Information
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03 April 2024, FDA Approves New Antibiotic for Three Different Uses
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