WALTHAM, Mass.– Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., has announced the U.S. commercial launch of ZEVTERA® (ceftobiprole medocaril sodium for injection), marking a significant expansion of its antibiotic portfolio. ZEVTERA is the first advanced-generation cephalosporin approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Staphylococcus aureus bloodstream infections (SAB), including right-sided endocarditis caused by both methicillin-susceptible and methicillin-resistant strains.
This marks the first FDA-approved MRSA-targeted SAB therapy since 2006. According to Innoviva, ZEVTERA offers physicians a new tool for combating drug-resistant pathogens, particularly in high-risk hospital and outpatient settings.
“The availability of ZEVTERA in the U.S. marks the introduction of our second novel therapy in two years,” said Pavel Raifeld, CEO of Innoviva, Inc. “This reflects our strategic commitment to expanding treatment options for serious infections that remain difficult to treat.”
Methicillin-resistant Staphylococcus aureus (MRSA) is a major public health concern due to its resistance to commonly used antibiotics. In the U.S., more than 100,000 people each year develop SAB, with nearly 20,000 deaths annually. Despite current therapies, mortality remains high—reaching nearly 30% within 90 days. MRSA infections are linked to longer hospital stays, increased systemic infections, and higher treatment costs compared to methicillin-susceptible strains.
ZEVTERA was approved by the FDA in April 2024 for three indications: adult SAB, including right-sided endocarditis; adult acute bacterial skin and skin structure infections (ABSSSI); and community-acquired bacterial pneumonia (CABP) in both adults and pediatric patients as young as three months. It is the only MRSA-active cephalosporin currently approved for use in the U.S.
Unlike earlier-generation cephalosporins, ZEVTERA has activity against both Gram-positive and Gram-negative bacteria, including MRSA. In the Phase 3 ERADICATE trial, ZEVTERA demonstrated non-inferiority to daptomycin, with or without aztreonam, in treating SAB. The success rate in the modified intention-to-treat population was 69.8% for ceftobiprole compared to 68.7% for daptomycin. Both treatments were well tolerated, with similar rates of adverse events.
“ZEVTERA is an excellent addition to our antibiotics portfolio and further underscores our mission to bring innovative infectious disease treatments to market,” said Dr. David Altarac, Chief Medical Officer of Innoviva Specialty Therapeutics. “With its approval for three serious infections, we are ensuring nationwide access through partnerships with specialty pharmacies and distributors.”
ZEVTERA is administered via intravenous infusion and is supplied in single-dose vials containing 667 mg of ceftobiprole medocaril sodium (equivalent to 500 mg of ceftobiprole). The drug was originally developed by Swiss biopharmaceutical company Basilea Pharmaceutica Ltd., and was granted Priority Review, Fast Track, and Qualified Infectious Disease Product designations by the FDA.
Innoviva secured exclusive U.S. commercialization rights through a licensing agreement with Basilea in December 2024.
David Veitch, CEO of Basilea, welcomed the launch. “The U.S. is the most important market for innovative antibacterials,” he said. “There is a clear need for new treatments targeting Staphylococcus aureus infections, and we are proud to partner with Innoviva in bringing ZEVTERA to patients in need.”
