FDA Greenlights Versatile Antibiotic for Triple Use

April 30, 2024

The U.S. Food and Drug Administration has given the approval to Zevtera (ceftobiprole medocaril sodium for injection) for multiple therapeutic uses. This includes treating Staphylococcus aureus bloodstream infections (bacteremia) (SAB) in adults, including those with right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSI) in adults, and community-acquired bacterial pneumonia (CABP) in pediatric patients aged three months to less than 18 years.

Dr. Peter Kim, Director of the Division of Anti-Infectives at the FDA’s Center for Drug Evaluation and Research, emphasized the agency's commitment to expanding antibiotic options to address serious bacterial infections. Zevtera underwent rigorous evaluation, including a randomized, controlled trial comparing its efficacy in treating SAB to a comparator. Results showed a favorable overall success rate of 69.8% with Zevtera compared to 68.7% with the comparator, further supporting its approval.

SOURCE: https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses