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ZEVTERA® (ceftobiprole), an Advanced-Generation Cephalosporin Antibiotic Now Commercially Available in the U.S. to Treat Three Types of Bacterial Infections
ZEVTERA is the first and only U.S. Food and Drug Administration-approved cephalosporin indicated to treat Staphylococcus aureus bacteremia (SAB), including
About this update from Innoviva, Inc.
[{"type":"text","content":"\n\nZEVTERA 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).\n\n\n WALTHAM, Mass.--(BUSINESS WIRE)--\nInnoviva 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.\n\n“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.”\n\nMRSA, 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.\n\nIn 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\n\nUnlike earlier-generation cephalosporin...