The US Food and Drug Administration (FDA) yesterday approved the novel antibiotic Zevtera (ceftobiprole medocaril sodium for injection) for treating serious bacterial infections in adults and children.
The approval of the cephalosporin antibiotic is for three indications: (1) Staphylococcus aureus bacteremia (SAB), including right-sided infective endocarditis, in adults; (2) acute bacterial skin and skin-structure infection (ABSSSI) in adults; (3) and community-acquired bacterial pneumonia (CABP) in adults and children as young as 3 months.
"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," Peter Kim, MD, MS, director of the Division of Anti-Infectives in the FDA's Center for Drug Evaluation and Research, said in an agency press release.
Broad clinical utility
The approval was based on evidence from three phase 3 clinical trials. In the ERADICATE trial, Zevtera was found to be noninferior to daptomycin for overall treatment success at 70 days post-treatment in adults hospitalized with complicated SAB, including infections caused by methicillin-resistant S aureus. That result was significant, given the limited treatment options for SAB, which has a high mortality rate.
The TARGET trial demonstrated that Zevtera was noninferior to vancomycin plus aztreonam in terms of early clinical response in adults with ABSSSI. In a trial involving adults with CABP, treatment with Zevtera resulted in competitive clinical cure rates compared with ceftriaxone with optional linezolid.
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.
The approval for Zevtera in children with CABP was based on evidence from the adult trial plus ad a smaller trial that included 138 pediatric patients ages 3 months to less than 18 years.
The approval was granted to Swiss biopharmaceutical company Basilea Pharmaceutica. Prior to FDA approval, Zevtera was approved in several countries in Europe and elsewhere for treating adults with CABP and hospital-acquired pneumonia.
"This approval is a landmark for ceftobiprole and reflects its broad clinical utility," Basilea chief medical officer Marc Engelhardt, MD, said in a company press release.