ZEVTERA is the first and only U.S. Food and Drug Administration-approved cephalosporin indicated to treat Staphylococcus aureus bacteremia (SAB), including right-sided endocarditis, caused by the methicillin-resistant Staphylococcus aureus (MRSA).
Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced the United States commercial availability of ZEVTERA® (ceftobiprole medocaril sodium for injection), the newest addition to the Company’s growing antibiotic portfolio. ZEVTERA is the only U.S. Food and Drug Administration (FDA) approved advanced-generation cephalosporin indicated to treat adult patients with Staphylococcus aureus bloodstream infection (bacteremia) (SAB), including those with right-side endocarditis caused by methicillin-susceptible and methicillin-resistant isolates.i ZEVTERA is the latest approved MRSA SAB therapy since 2006.
“The availability of ZEVTERA in the U.S. marks the introduction of our second novel therapy in two years, addressing drug-resistant pathogens that pose significant health risks, particularly in hospitals and out-patient settings,” said Pavel Raifeld, Chief Executive Officer, Innoviva, Inc. “This portfolio expansion demonstrates our commitment to delivering therapies that offer physicians new options for treating some of the most challenging and potentially deadly diseases by leveraging our market-leading hospital platform.”
MRSA, a strain of Staphylococcus aureus, has developed resistance to methicillin and many other commonly used antibiotics. Infections with MRSA have a high morbidity and mortality rate. Each year, over one hundred thousand individuals in the U.S. experience bacteremia caused by Staphylococcus aureus, with nearly 20,000 of these cases resulting in death.
In April 2024, the U.S. FDA approved ZEVTERA for three indications. It is the only FDA-approved MRSA cephalosporin antibiotic for treating adult patients with SAB and right-side endocarditis. In addition to Staphylococcus aureus bacteremia, ZEVTERA is indicated for the treatment of adult patients 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).ii
Unlike earlier-generation cephalosporins, ZEVTERA retains effectiveness against Gram-negative bacteria and provides activity against MRSA and methicillin-susceptible Staphylococcus aureus (MSSA). In the Phase 3 ERADICATE study, ceftobiprole met the primary endpoint by demonstrating non-inferiority versus daptomycin, with or without aztreonam. 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.iii
“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,” said David Altarac, M.D., Chief Medical Officer, Innoviva Specialty Therapeutics, Inc. “With the approval of ZEVTERA for three different indications, physicians and other health care providers will have a new option for serious bacterial infections, including Staphylococcal aureus bacteremia caused by methicillin-susceptible and methicillin-resistant isolates. Through our collaboration with specialty pharmacies and pharmacy distributors nationwide, ZEVTERA is available for immediate access.”
Despite the availability of standard-of-care therapies, the mortality rate for SAB remains high, with approximately 30% of patients succumbing to the infection at 90 days.iv Patients with MRSA are three times more likely to experience prolonged bacteremia compared to those with methicillin-sensitive Staphylococcus aureus. Furthermore, MRSA bacteremia increased hospital length of stay and systemic infection vs. methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia.v
ZEVTERA is supplied in a single-dose vial containing 667 mg of ceftobiprole medocaril sodium (equivalent to 500 mg of ceftobiprole) as a lyophilized powder for intravenous infusion after reconstitution. Please visit www.innovivaspecialtytherapeutics.com for more information.
ZEVTERA was developed by Basilea Pharmaceutica Ltd, Allschwil (“Basilea”) and received Priority Review, Fast Track, and Qualified Infectious Disease Product designations for the CABP, ABSSSI, and SAB indications. In December 2024, Innoviva Specialty Therapeutics, Inc., acquired exclusive U.S. marketing rights through a licensing agreement with Basilea.
“We congratulate our partner Innoviva Specialty Therapeutics on making ZEVTERA available in the U.S., which marks a significant milestone for the brand,” said David Veitch, Chief Executive Officer of Basilea. “The U.S. is the most critical commercial market for newer antibacterials, and there is a substantial medical need for treatments targeting Staphylococcus aureus infections, particularly Staphylococcus aureus bacteremia. We are excited to support Innoviva Specialty Therapeutics in bringing ZEVTERA to patients in the U.S. who are suffering from these severe infections.”
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