The injection received FDA approval for adults and pediatric patients aged 3 months and older.
RT’s Three Key Takeaways
- Zevtera received FDA approval for the treatment of community-acquired bacterial pneumonia in both adults and pediatric patients aged 3 months to less than 18 years.
- The drug also was approved for adults with Staphylococcus aureus bloodstream infections and adults with acute bacterial skin and skin structure infections.
- Zevtera achieved 76.4% clinical cure compared to 79.3% of subjects who received the comparator in a clinical trial in adults with community-acquired bacterial pneumonia.
Today, the US Food and Drug Administration (FDA) approved a new antibiotic, Zevtera (ceftobiprole medocaril sodium for injection), for three uses, including the treatment of adult and pediatric patients 3 months to less than 18 years old with community-acquired bacterial pneumonia (CABP).
The drug also was approved for adults with Staphylococcus aureus bloodstream infections and adults with acute bacterial skin and skin structure infections.
“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,” says Peter Kim, MD, MS, director of the division of anti-infectives in the FDA’s Center for Drug Evaluation and Research, in a release. “The FDA will continue our important work in this area as part of our efforts to protect the public health.”
Evaluating Zevtera’s Efficacy for CABP
Zevtera’s efficacy in treating adult patients with CABP was evaluated in a randomized, controlled, double-blind, multinational, multicenter trial. In the trial, researchers randomly assigned 638 adults hospitalized with CABP and requiring IV antibacterial treatment for at least three days to receive either Zevtera (314 subjects) or ceftriaxone with optional linezolid (324 subjects).
The primary measurement of efficacy was clinical cure rates at test-of-cure visit, which occurred seven to 14 days after treatment. Of the subjects who received Zevtera, 76.4% achieved clinical cure compared to 79.3% of subjects who received the comparator. An additional analysis considered an earlier timepoint of clinical success at day 3, which was 71% in patients receiving Zevtera and 71.1% in patients receiving the comparator.
Given the similar course of CABP in adults and pediatric patients, the approval of Zevtera in pediatric patients 3 months to less than 18 years with CABP was supported by evidence from the CABP trial of Zevtera in adults and a trial in 138 pediatric subjects three months to less than 18 years of age with pneumonia.
Side Effects of Zevtera
For adults with CABP, the most common side effects of Zevtera included nausea, increased levels of hepatic enzymes, vomiting, diarrhea, headache, rash, insomnia, abdominal pain, vein inflammation (phlebitis), high blood pressure, and dizziness. For pediatric patients with CABP, the most common side effects of Zevtera included vomiting, headache, increased levels of hepatic enzymes, diarrhea, infusion site reaction, vein inflammation (phlebitis), and fever.
Patients should not use Zevtera if they have a known history of severe hypersensitivity to ceftobiprole or any of the components of Zevtera, or other members of the cephalosporin antibacterial class.
Zevtera comes with certain warnings and precautions, such as 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.
Zevtera was granted Priority Review, Fast Track, and Qualified Infectious Disease Product designations for the three approved indications.
The FDA granted the approval of Zevtera to Basilea Pharmaceutica International Ltd.
