FDA Approves Zevtera for Bacterial Infections: What You Need to Know

Zevtera (ceftobiprole medocaril sodium for injection) has received approval from the US Food and Drug Administration (FDA) for treating various bacterial infections in adults and pediatric patients. This includes Staphylococcus aureus bloodstream infections (SAB) (bacteremia), specifically focusing on right-sided infective endocarditis in adults. Additionally, Zevtera is approved for adults with acute bacterial skin and skin structure infections (ABSSSI) and pediatric patients aged 3 months to less than 18 years with community-acquired bacterial pneumonia (CABP).

“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 several serious bacterial infections,” said Peter Kim, MD, MS, director of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research stated in the announcement. “The FDA will continue our important work in this area as part of our efforts to protect the public health.”

In adults diagnosed with SAB, Zevtera may present common side effects such as anemia, nausea, hypokalemia (low blood potassium levels), vomiting, diarrhea, elevated liver enzymes, increased blood creatinine, high blood pressure, leukopenia (low white blood cell count), fever, abdominal pain, fungal infections, headache, and dyspnea (shortness of breath).

Zevtera's effectiveness against SAB was evaluated in a double-blind trial involving 390 subjects. The subjects were randomized to receive either Zevtera or the comparator group (daptomycin plus optional aztreonam). The primary measure of success was overall success, which included survival, symptom improvement, bloodstream clearance of S aureus bacteremia, no new S aureus bacteremia complications, and no use of other antibiotics. The post-treatment evaluation visit took place 70 days after the start of the treatment. The results showed that 69.8% of Zevtera subjects achieved overall success compared to 68.7% of the comparator group.

Patients receiving Zevtera treatment for acute bacterial skin and skin structure infections (ABSSSI) may experience side effects, including nausea, diarrhea, headache, injection site reactions, elevated liver enzymes, rash, vomiting, and altered taste (dysgeusia).

For adults with community-acquired bacterial pneumonia (CABP), common side effects of Zevtera might include nausea, increased liver enzyme levels, vomiting, diarrhea, headache, rash, insomnia, abdominal pain, phlebitis (vein inflammation), high blood pressure, and dizziness. Pediatric patients being treated for CABP with Zevtera may experience side effects like vomiting, headache, increased liver enzyme levels, diarrhea, infusion site reactions, phlebitis, and fever.

Zevtera's efficacy in treating CABP was evaluated in a double-blind, randomized, multicenter trial. Researchers assigned 638 hospitalized adults to receive either Zevtera or a comparator. Clinical cure rates at test-of-cure visits were measured, with 76.4% of Zevtera recipients achieving clinical cure compared to 79.3% of comparator recipients. Clinical success rates on day 3 were 71% for Zevtera and 71.1% for the comparator.

Additionally, Zevtera has been approved for treating CABP in pediatric patients aged 3 months to less than 18 years. This approval is supported by 2 trials: 1 in adults with CABP and a trial in 138 pediatric subjects aged 3 months to less than 18 years with pneumonia. The approval considers a similar CABP course in adult and pediatric patients.

Patients should avoid using Zevtera if they have a known history of severe hypersensitivity to ceftobiprole or any of the drug's components or if they have had reactions to other medications in the cephalosporin antibacterial class.

Zevtera comes with specific warnings and precautions, including the potential for increased mortality in ventilator-associated bacterial pneumonia patients (an unapproved use), hypersensitivity reactions, seizures, other central nervous system reactions, and the risk of Clostridioides difficile-associated diarrhea. Patients should consult their health care providers for comprehensive information and guidance on using Zevtera appropriately for their specific condition.