FDA Approves Antibiotic Zevtera to Treat Multiple Serious Infections – Renal and Urology News

The Food and Drug Administration (FDA) has approved Zevtera^® (ceftobiprole medocaril) for the treatment of: adults with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis; adults with acute bacterial skin and skin structure infections (ABSSSI); and adult and pediatric patients 3 months to less than 18 years of age with community-acquired bacterial pneumonia (CABP).

Zevtera is a cephalosporin antibacterial with in vitro activity against gram-positive and gram-negative bacteria, including methicillin-resistant and susceptible Staphylococcus aureus. The approval was based on data from the three phase 3 studies, including ERADICATE (ClinicalTrials.gov Identifier: NCT03138733), TARGET (ClinicalTrials.gov Identifier: NCT03137173), and a phase 3 study in CABP (ClinicalTrials.gov Identifier: NCT00326287). 

The ERADICATE study compared ceftobiprole to daptomycin with or without aztreonam, in 390 patients with complicated SAB. Findings showed treatment with ceftobiprole met the primary endpoint of overall success demonstrating noninferiority to daptomycin in the modified intent-to-treat population (ITT) at 70 days postrandomization (69.8% vs 68.7%, respectively; statistically adjusted difference of 2.0% [95% CI, -7.1, 11.1]). Microbiological eradication rate was 82.0% with ceftobiprole vs 77.3% with daptomycin, all-cause mortality rate was 9.0% with ceftobiprole vs 9.1% with daptomycin, and the emergence of new SAB complications was 6% with ceftobiprole vs 6% with daptomycin.

The TARGET study compared ceftobiprole to vancomycin plus aztreonam in 679 patients with ABSSSI. Findings showed treatment with ceftobiprole met the primary endpoint of early clinical response demonstrating noninferiority to vancomycin plus aztreonam in the ITT population (91.3% vs 88.1%, respectively; adjusted difference of 3.3% [95% CI, -1.2, 7.8]). Early clinical response was defined as a reduction of at least 20% from baseline in lesion size at 48 to 72 hours after treatment. Moreover, ceftobiprole was noninferior to vancomycin plus aztreonam for clinical success (90.1% vs 89.0%, respectively; adjusted difference of 1.0% [95% CI, -3.5, 5.6]), which was defined as complete or nearly complete resolution of baseline signs and symptoms of infection at the test-of-cure visit 15 to 22 days after randomization. 

Lastly, a phase 3 study compared ceftobiprole to ceftriaxone, with or without linezolid, in 638 patients with CABP. Findings showed treatment with ceftobiprole met the primary endpoint of clinical cure at the test-of-cure visit at day 7 to 14 in the ITT population demonstrating noninferiority to ceftriaxone with or without linezolid (76.4% vs 79.3%, respectively; adjusted difference of -2.9% [95% CI, -9.3, 3.6]). The all-cause mortality rate in the ITT population was 1.6% with ceftobiprole vs 2.5% with ceftriaxone with or without linezolid.

“We are very pleased that the FDA approved Zevtera for all 3 indications that were submitted with the NDA, including a pediatric labeling,” said Dr Marc Engelhardt, Chief Medical Officer of Basilea. “This approval is a landmark for ceftobiprole and reflects its broad clinical utility. The indication in adult patients with Staphylococcus aureus bacteremia, including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates, MSSA and MRSA, addresses a real medical need, as current treatment options are limited.”

Zevtera is supplied in a single-dose vial containing 667mg of ceftobiprole medocaril sodium (equivalent to 500mg of ceftobiprole) as a lyophilized powder for intravenous infusion after reconstitution.

This article originally appeared on MPR