On April 3, the FDA approved Zevtera, an antibiotic with three different uses.
The medication is indicated for adults with Staphylococcus aureus bloodstream infections, including right-sided infective endocarditis; acute bacterial skin and skin structure infections; and community-acquired bacterial pneumonia. It is also approved for children with bacterial pneumonia.
In a trial to evaluate its effectiveness in treating S. aureus, Zevtera (ceftobiprole medocaril sodium for injection) was compared to daptomycin and another optional antibiotic, aztreonam. Researchers tested for survival, symptom improvement, S. aureus bacteremia bloodstream clearance, no new S. aureus bacteremia complications, and no use of other potentially effective antibiotics.
After 70 days, 69.8% of Zevtara patients and 68.7% of the other cohort achieved overall success.
Basilea Pharmaceutica International is the manufacturer of Zevtara, which achieved the FDA's priority review, fast track and qualified infectious disease product designations.