FDA Approves Zevtera for Treatment of Serious Bacterial Infections

The U.S. Food and Drug Administration (FDA) has granted approval to Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of various bacterial infections in adults and pediatric patients. Zevtera can now be used for the treatment of Staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP) in pediatric patients aged three months to less than 18 years old.

Director of the Division of Anti-Infectives in the FDA's Center for Drug Evaluation and Research, Dr. Peter Kim, expressed the agency's commitment to providing new antibiotic options that are both safe and effective. Zevtera, a medication developed by Basilea Pharmaceutica International Ltd., will offer an additional treatment choice for patients suffering from serious bacterial infections.

The effectiveness of Zevtera in treating Staphylococcus aureus bloodstream infections (SAB) was evaluated in a clinical trial involving 390 subjects. The trial showed that 69.8% of those who received Zevtera achieved overall success, comparable to the success rate of 68.7% for patients who received the comparator.

In another trial involving 679 patients with acute bacterial skin and skin structure infections (ABSSSI), Zevtera demonstrated a high rate of early clinical response. Within 48-72 hours after the start of treatment, 91.3% of subjects who received Zevtera showed improvement, compared to 88.1% of patients in the comparator group.

For adult patients with community-acquired bacterial pneumonia (CABP), a randomized trial involving 638 individuals evaluated the effectiveness of Zevtera. The results showed that 76.4% of patients treated with Zevtera achieved clinical cure, slightly lower than the 79.3% success rate for those who received the comparator.

The approval of Zevtera for pediatric patients with community-acquired bacterial pneumonia (CABP) was supported by evidence from the adult CABP trial and a separate trial involving 138 pediatric subjects.

Common side effects of Zevtera varied depending on the specific condition being treated. For adults with Staphylococcus aureus bloodstream infections (SAB), anemia, nausea, and low levels of potassium in the blood were among the most reported side effects. Nausea, diarrhea, and headache were the commonly reported side effects in adults with acute bacterial skin and skin structure infections (ABSSSI) who received Zevtera. In adults and pediatric patients with community-acquired bacterial pneumonia (CABP), nausea, increased levels of hepatic enzymes, and vomiting were the most commonly reported side effects.

Patients who have a known history of severe hypersensitivity to ceftobiprole or any components of Zevtera, or other members of the cephalosporin antibacterial class, should not use this medication.

Zevtera was granted Priority Review, Fast Track, and Qualified Infectious Disease Product designations for the treatment of community-acquired bacterial pneumonia (CABP), acute bacterial skin and skin structure infections (ABSSSI), and Staphylococcus aureus bloodstream infections (SAB).

The FDA continues to focus on ensuring the availability of new antibiotics to protect public health. The agency's approval of Zevtera marks an important milestone in the fight against serious bacterial infections.

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