Zevtera approved for community-acquired bacterial pneumonia in infants, adolescents, teens
The pediatric approval to treat CABP is 1 of 3 indications approved by the FDA.
Zevtera approved for community-acquired bacterial pneumonia in infants, adolescents, teens | Image Credit: © Calin - © Calin - stock.adobe.com.
The FDA has approved Zevtera (ceftobiprole medocaril sodium for injection; Basilea Pharmaceutica International) in pediatric patients aged 3 months to less than 18 years, and adults, with community-aquired becterial pneumonia (CABP), according to a press release from the federal agency.1
The decision also comes with Zevtera approval to treat Staphylococcus aureus bloodstream infections, including those with right-sided infective endocarditis in adults. Further, treatment is also indicated for adults with acute bacterial skin and skin structure infections.1
"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," said Peter Kim, MD, MS, director, Division of Anti-Infectives, Center for Drug Evaluation and Research, FDA, in a statement.1
"The FDA will continue our important work in this area as part of our efforts to protect the public health," Kim added.1
According to the FDA, given the similar course of CABP in adults and pediatric patients, Zevtera's approval for the pediatric indication was supported by data from the CABP trial in adults, and a phase 3 clinical trial (NCT03439124) in 138 patients aged 3 months to 17 years.1,2
In this population, the most common side effects of Zevtera included vomiting, headache, increased levels of hepatic enzymes, infusion site reaction, diarrhea, vein inflammation, and fever.1
In the adult study that supported the pediatric approval, patients, who were hospitalized with CABP and required IV antibacterial treatment for at least 3 days, were randomly assigned to receive Zevtera or ceftriaxone with optional linezolid (comparator).1
Clinical cure rates at test-of-cure visit was the primary measurement of efficacy. In the Zevtera group, 76.4% of patients achieved clinical cure compared to 79.3% of subjects who received the comparator.1
An earlier timepoint of clinical success at day 3 was considered in an additional analysis, which was 71% of patients in the Zevtera group, and 71.1% of patients in the comparator group.1
References:
1. FDA approves new antibiotic for three different uses. FDA. Press release. April 3, 2024. Accessed April 3, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses?utm_medium=email&utm_source=govdelivery
2. Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia. ClinicalTrials.gov. Updated May 12, 2023. Accessed April 3, 2024. https://www.clinicaltrials.gov/study/NCT03439124
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