US drugmaker Innoviva Specialty Therapeutics announced today that the novel cephalosporin antibiotic Zevtera (ceftobiprole medocaril sodium for injection) is now commercially available in the United States.
Zevtera is an advanced-generation cephalosporin with effectiveness against gram-positive and gram-negative bacteria. It was approved by the US Food and Drug Administration (FDA) in April 2024 for three indications: (1) methicillin-resistant and methicillin-susceptible Staphylococcus aureus bacteremia (SAB), including right-sided infective endocarditis, in adults; (2) acute bacterial skin and skin-structure infection in adults; (3) and community-acquired bacterial pneumonia in adults and children as young as 3 months.
The approval was granted to Swiss biopharmaceutical company Basilea Pharmaceutica, which sold the rights to market the drug in the United States to Innoviva in December 2024.
New option for potentially deadly infections
Company officials say Zevtera offers physicians a new option for treating challenging and potentially deadly infections. Approximately 100,000 cases of SAB occur every year in the United States, with nearly 20,000 deaths. The 90-day mortality rate is roughly 30%.
"Zevtera is an excellent addition to our antibiotics portfolio and its market availability further underscores our strategic commitment to deliver meaningful innovations in infectious diseases," Innoviva Chief Medical Officer David Altarac, MD, said in a company press release.