The US Food & Drug Administration (FDA) has approved the injectable drug ceftobiprole medocaril sodium (Zevtera) to treat adults with Staphylococcus aureus bacteremia (SAB), the agency announced last week.
The antibiotic prodrug is indicated for people with right-sided infective endocarditis, those with acute bacterial skin and skin structure infections (ABSSSI), and adult and paediatric patients aged from three months to 18-years-old with community-acquired bacterial pneumonia (CABP).
Ceftobiprole, a pyrrolidinone cephalosporin antibiotic, is the active moiety of the prodrug ceftobiprole medocaril.
Medpage Today reports that ceftobiprole medocaril’s efficacy in treating SAB was evaluated in a randomised controlled multinational trial involving 390 participants assigned to receive either the drug or daptomycin plus optional aztreonam.
A total of 69.8% of participants who received ceftobiprole medocaril achieved overall success – defined as survival, symptom improvement, bloodstream clearance of SAB, and no new complications – compared with 68.7% of those who received a comparator.
The drug’s efficacy in treating ABSSSI was evaluated in a multinational trial in which 679 participants were randomly assigned to receive either ceftobiprole medocaril or vancomycin plus aztreonam.
Of those who received ceftobiprole medocaril, 91.3% achieved an early clinical response – reduction of primary skin lesion by at least 20%, survival for at least 72 hours, and no additional antibacterial treatment or unplanned surgery within the necessary 48-to-72-hour timeframe – compared with 88.1% of people who received a comparator.
Ceftobiprole medocaril’s efficacy in treating patients with CABP was evaluated in a multinational trial of 638 adults hospitalised with CABP and requiring IV antibacterial treatment for at least three days, who were randomly assigned to receive either ceftobiprole medocaril or ceftriaxone with optional linezolid.
Of those who received the former, 76.4% achieved clinical cure seven-to-14 days after treatment ended, compared with 79.3% of people who received the comparator.
An additional analysis looked at an earlier time-point of clinical success at day three, which was 71% in patients receiving the study drug and 71.1% in patients receiving the comparator.
The approval of ceftobiprole medocaril was also supported by evidence from the CABP trial of ceftobiprole medocaril in adults and in paediatric participants.
Common side effects for each of the three indications included nausea, vomiting and diarrhoea. Some participants with SAB experienced additional side effects including hypertension, leukopenia, fungal infection, headache and dyspnoea.
For paediatric patients with CABP, the most common side effects of ceftobiprole medocaril included vomiting, headache, increased levels of hepatic enzymes, diarrhoea, infusion site reaction, phlebitis, and fever.
FDA approval of ceftobiprole medocaril was granted to Basilea Pharmaceutica International.
Medpage Today article – FDA OKs Injectable Antibiotic for Three Different Uses (Open access)
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