FDA Approves New Antibiotic for Three Indications
By Lori Solomon HealthDay Reporter
MONDAY, April 8, 2024 -- The U.S. Food and Drug Administration has approved the antibiotic Zevtera (ceftobiprole medocaril sodium for injection) for three different indications, including treatment of adults with Staphylococcus aureus bloodstream infections, adults with acute bacterial skin and skin structure infections, and adult and pediatric patients (age 3 months and older) with community-acquired bacterial pneumonia.
The priority review approval was based on four randomized controlled trials. For S. aureus bloodstream infections, a trial with 390 participants showed 69.8 percent of those receiving Zevtera achieved overall success (survival, symptom improvement, S. aureus bacteremia bloodstream clearance, no new S. aureus bacteremia complications, and no use of other potentially effective antibiotics) versus 68.7 percent of those receiving the comparator. For acute bacterial skin and skin structure infections, among 679 participants, 91.3 percent of those receiving Zevtera achieved an early clinical response (48 to 72 hours after start of treatment) versus 88.1 percent of those receiving the comparator. For community-acquired bacterial pneumonia, efficacy (clinical cure rates at test-of-cure visit at seven to 14 days after end of treatment) occurred in 76.4 percent with Zevtera versus 79.3 percent of those receiving the comparator.
Patients should not use Zevtera if they have a history of severe hypersensitivity to ceftobiprole or other members of the cephalosporin antibacterial class. Additionally, Zevtera comes with warnings and precautions regarding increased mortality in ventilator-associated bacterial pneumonia patients (an unapproved use), hypersensitivity reactions, seizures and other central nervous system reactions, and Clostridioides difficile-associated diarrhea.
"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," Peter Kim, M.D., from the FDA Center for Drug Evaluation and Research, said in a statement.
Approval of Zevtera was granted to Basilea Pharmaceutica International.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2024 HealthDay. All rights reserved.
Posted April 2024
Read this next
Disparities Seen in Carbapenem-Resistant Enterobacterales Bloodstream Infection Outcomes
TUESDAY, May 14, 2024 -- Black female patients hospitalized for carbapenem-resistant Enterobacterales (CRE) bloodstream infections (BSI) face increased 30-day mortality, according...
Following Drop After COVID-19 Onset, Inappropriate Antibiotic Prescribing Is Up
WEDNESDAY, May 1, 2024 -- There was an initial decrease in inappropriate antibiotic prescriptions following onset of COVID-19, followed by an increase, according to a study...
Multisite QI Collaborative Increases Appropriate Pediatric Antibiotic Use
MONDAY, April 29, 2024 -- A multisite collaborative increases appropriate antibiotic use for pediatric community-acquired pneumonia, skin and soft tissue infections, and urinary...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.