Ceftobiprole Launches Commercially in US
Innoviva Specialty Therapeutics’ antibiotic is the first and only FDA-approved cephalosporin indicated to treat Staphylococcus aureus bacteremia (SAB), including right-sided endocarditis, caused by the methicillin-resistant Staphylococcus aureus (MRSA).
Today, Innoviva Specialty Therapeutics, which is a subsidiary of Innoviva, announced its antibiotic, ceftobiprole (Zevtera), is available for prescribing in the US. The antibiotic was approved in April 2024, and now marks the first cephalosporin indicated to treat SAB.1
“The availability of Zevtera in the US marks the introduction of our second novel therapy in 2 years, addressing drug-resistant pathogens that pose significant health risks, particularly in hospitals and out-patient settings,” said Innoviva CEO Pavel Raifeld, said in a statement.1
In addition to being indicated for treating adults with Staphylococcus aureus bloodstream infections, including those with right-sided infective endocarditis, it can be prescribed for adults with acute bacterial skin and skin structure infections (ABSSSI), and adult and pediatric patients 3 months to less than 18 years old with community-acquired bacterial pneumonia (CABP).
Study Data
SAB. In the phase 3 ERADICATE study, ceftobiprole met the primary endpoint by demonstrating non-inferiority versus daptomycin, with or without aztreonam for SAB. The overall success rate was 69.8% with ceftobiprole, compared to 68.7% with daptomycin, in the Modified Intention-to-Treat (mITT) population at 70 days post-randomization. Both treatments were well tolerated. The overall rate of adverse events was similar between the ceftobiprole and daptomycin groups.1
In the trial, researchers randomly assigned 390 subjects to receive Zevtera (192 subjects) or daptomycin plus optional aztreonam [the comparator] (198 subjects). The primary measure of efficacy for this trial was the overall success (defined as survival, symptom improvement, S aureus bacteremia bloodstream clearance, no new S aureus bacteremia complications and no use of other potentially effective antibiotics) at the post-treatment evaluation visit, which occurred 70 days after being randomly assigned an antibiotic.2
ABSSSI. Ceftobiprole’s efficacy in treating ABSSSI was evaluated in a randomized, controlled, double-blind, multinational trial. In the trial, researchers randomly assigned 679 subjects to receive either ceftobiprole (335 subjects) or vancomycin plus aztreonam [the comparator] (344 subjects). 2
The primary measure of efficacy was early clinical response 48-72 hours after start of treatment. Early clinical response required a reduction of the primary skin lesion by at least 20%, survival for at least 72 hours and the absence of additional antibacterial treatment or unplanned surgery. Of the subjects who received ceftobiprole, 91.3% achieved an early clinical response within the necessary timeframe compared to 88.1% of subjects who received the comparator. 2
CABP. Ceftobiprole’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 3 days to receive either ceftobiprole (314 subjects) or ceftriaxone with optional linezolid [the comparator] (324 subjects). The primary measurement of efficacy were clinical cure rates at test-of-cure visit, which occurred 7-14 days after end-of-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 ceftobiprole and 71.1% in patients receiving the comparator.2
Outside the US, the brand is currently approved and marketed in several European countries and beyond as Zevtera and Mabelio for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of CABP. Basilea has entered into license and distribution agreements covering more than 80 countries.1
