The FDA approved ceftobiprole medocaril sodium injection (Zevtera; Basilea Pharmaceutica) for the treatment of 3 new indications, according to a press release from the agency. The indications include adults with Staphylococcus aureus bloodstream (SAB) infections, including right-sided infective endocarditis; adults with acute bacterial skin and skin structure infections; and adult and pediatric individuals aged 3 to less than 18 years old with community-acquired bacterial pneumonia (CAP).
"The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and [ceftobiprole medocaril sodium] will provide an additional treatment option for a number of serious bacterial infections," Peter Kim, MD, MS, director of the Division of Anti-Infectives in the Center for Drug Evaluation and Research at the FDA, said in the press release. "The FDA will continue our important work in this area as part of our efforts to protect the public health."
The approvals were based on 3 randomized controlled trials. Trial 1 (NCT03138733) investigated the treatment of SAB, trial 2 (NCT03137173) investigated acute bacterial skin and skin structure infections, and trial 3 (NCT00326287) investigated CAP.
About The Trials
Trial 1
Trial Name: Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia
ClinicalTrial.gov ID: NCT03138733
Sponsor: Basilea Pharmaceutica
Completion Date: March 2022
Trial 2
Trial Name: Ceftobiprole in the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections
ClinicalTrial.gov ID: NCT03137173
Sponsor: Basilea Pharmaceutica
Completion Date: April 2019
Trial 3
Trial Name: Ceftobiprole in the Treatment of Patients With Community-Acquired Pneumonia
ClinicalTrial.gov ID: NCT00326287
Sponsor: Basilea Pharmaceutica
Completion Date: July 2009
Trial 4
Trial Name: Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia
ClinicalTrial.gov ID: NCT03439124
Sponsor: Basilea Pharmaceutica
Completion Date: March 2020
In trial 1, investigators randomly assigned treatment with either ceftobiprole medocaril sodium or daptomycin plus optional aztreonam to 390 individuals. The primary efficacy endpoint included the overall success at the post-treatment evaluation occurring 70 after treatment was assigned, including measures of survival, symptom improvement, S. aureus bacteremia bloodstream clearance, no new S. aureus bacteremia complications, and no use of other potentially effective antibiotics. Investigators reported that 69.8% of individuals receiving ceftobiprole medocaril sodium achieved overall success compared to 68.7% receiving the comparator, according to the press release.
The most common adverse events (AEs) in trial 1 included anemia, nausea, hypokalemia, vomiting, diarrhea, increased levels of certain liver tests, increased blood creatinine, high blood pressure, leukopenia, fever abdominal pain, fungal infection, headache, and dyspnea.
In trial 2, investigators assigned treatment with ceftobiprole medocaril sodium or vancomycin plus aztreonam to 679 individuals, with the primary efficacy endpoint of early clinical response at 48 to 72 hours after starting treatment. Early clinical response was defined as a reduction of primary skin lesions by at least 20%, survival for at least 72 hours, and the absence of additional antibacterial treatment or unplanned surgery, according to the press release. Of those receiving the study drug, 91.3% achieved an early clinical response with 88.1% in the comparator group.
The most common AEs included nausea, diarrhea, headache, injection site reaction, increase levels of hepatic enzymes, rash, vomiting, and dysgeusia.
In trial 3, investigators assigned treatment to 6638 adults hospitalized with CAP and requiring an intravenous antibacterial treatment for at least 3 days. Treatment included either ceftobiprole medocaril sodium or ceftriaxone with optional linezolid. The primary efficacy endpoint included clinical cure rates occurring 7 to 14 days after the end of treatment. Approximately 76.4% achieved this endpoint in the ceftobiprole medocaril sodium group compared to 79.3% in the comparator group. At an earlier time point of 3 days, the percentages of clinical success were 71% and 71.1%, respectively.
The most common AEs included nausea, increased levels of hepatic enzymes, vomiting, diarrhea, headache, rash, insomnia, abdominal pain, phlebitis, high blood pressure, and dizziness.
The approval of ceftobiprole medocaril sodium in pediatric individuals aged 3 months to less than 18 was based on another trial (NCT03439124) of ceftobiprole medocaril sodium for CAP in 138 pediatric individuals with pneumonia, according to the press release.
For pediatrics, the most common AEs included vomiting, headache, increased levels of hepatic enzymes, diarrhea, infusion site reaction, phlebitis, and fever.
Ceftobiprole medocaril sodium was previously granted priority review, fast track, and qualified infectious disease product designations for CAP, acute bacterial skin and skin structure infections, and SAB indications.
Reference
FDA Approves New Antibiotic for Three Different Uses. News release. FDA. April 3, 2024. Accessed April 4, 2024. https://prnmedia.prnewswire.com/news-releases/fda-approves-new-antibiotic-for-three-different-uses-302107661.html
