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Yahoo
20-05-2025
- Business
- Yahoo
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 right-sided endocarditis, caused by the methicillin-resistant Staphylococcus aureus (MRSA). WALTHAM, Mass., May 20, 2025--(BUSINESS WIRE)--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 "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 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 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." About MRSA According to the Centers for Disease Control and Prevention (CDC), methicillin-resistant Staphylococcus aureus (MRSA) is considered a serious public health threat. MRSA is a type of staph infection that has become resistant to commonly used antibiotics, including methicillin, oxacillin, penicillin, and amoxicillin. This resistance has contributed to MRSA's status as a significant public health concern. MRSA infections can lead to severe complications both in healthcare settings and in the community, including pneumonia, sepsis, surgical site infections, and endocarditis. Individuals at highest risk for contracting MRSA include those who have prolonged hospital stays, have been admitted to intensive care, underwent recent invasive procedures, or reside in nursing homes. Healthcare workers who come into direct contact with patients infected with MRSA are also at increased risk. About ZEVTERA® (ceftobiprole medocaril sodium for injection) Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced-generation cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria, such as Staphylococcus aureus, including methicillin-resistant strains (MRSA), and Gram-negative bacteria. Outside the U.S., the brand is currently approved and marketed in several European countries and beyond as ZEVTERA® and Mabelio® for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of community-acquired bacterial pneumonia (CABP). Basilea has entered into license and distribution agreements covering more than 80 countries. INDICATIONS & USAGE Indications ZEVTERA® (ceftobiprole medocaril sodium for injection), for intravenous use, is indicated for the treatment of: Adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates. Adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus (methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, and Klebsiella pneumoniae. Adult and pediatric patients (3 months to less than 18 years) with community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus (methicillin- susceptible isolates), Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Escherichia coli, and Klebsiella pneumoniae. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZEVTERA and other antibacterial drugs, ZEVTERA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. IMPORTANT SAFETY INFORMATION Contraindications: ZEVTERA is contraindicated in patients with a known history of severe hypersensitivity to ZEVTERA, or to other members of the cephalosporin class. Warnings and Precautions: Increased mortality with unapproved use in ventilator-associated bacterial pneumonia (VABP) Patients: The safety and effectiveness of ZEVTERA for the treatment of VABP has not been established and the use of ZEVTERA for VABP is not approved. Serious hypersensitivity reactions, including anaphylaxis, were observed in ZEVTERA-treated patients in clinical trials. Serious and occasionally fatal hypersensitivity reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with ZEVTERA is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or other beta-lactam antibacterial drugs should be made. Maintain clinical supervision if this product is to be given to a penicillin- or other beta-lactam-allergic patient, because cross sensitivity among beta-lactam antibacterial agents has been established. Discontinue ZEVTERA if a hypersensitivity reaction occurs, and institute appropriate treatment. Seizures and other adverse central nervous system (CNS) reactions have been reported during treatment with ZEVTERA and other cephalosporins. If CNS adverse reactions, including seizures, occur, evaluate patients to determine whether ZEVTERA should be discontinued. Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ZEVTERA, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, the risk/benefit of continuing treatment with ZEVTERA should be assessed. Adverse Reactions: SAB (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were anemia, nausea, hypokalemia, vomiting, hepatic enzyme and bilirubin increased, diarrhea, blood creatinine increased, hypertension, leukopenia, pyrexia, abdominal pain, fungal infection, headache, and dyspnea. ABSSSI (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, diarrhea, headache, injection site reaction, hepatic enzyme increase, rash, vomiting, and dysgeusia. CABP (adult and pediatric patients 3 months to less than 18 years of age): Adult Patients: The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, hepatic enzyme increased, vomiting, diarrhea, headache, rash, insomnia, abdominal pain, phlebitis, hypertension, and dizziness. Pediatric Patients: The most common adverse reactions occurring in ≥ 2% of pediatric patients were vomiting, headache, hepatic enzyme increased, diarrhea, infusion site reaction, phlebitis, and pyrexia. You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact: Innoviva Specialty Therapeutics, Inc.™ 1‑800‑651‑3861 medinfo@ U.S. Food and Drug Administration 1‑800‑FDA‑1088 For smaller pieces, AE language can be: To report suspected adverse reactions, contact Innoviva Specialty Therapeutics, Inc. at 1‑800‑651‑3861 (medinfo@ or the FDA at 1-800-FDA-1088 or For full prescribing information, go to: About Staphylococcus aureus bacteremia (SAB) Staphylococcus aureus bacteremia (SAB) is a serious bloodstream infection associated with significant morbidity and mortality. Complications include concomitant infections such as bone, joint or heart valve infections, persistent bacteremia or bacteremia in patients on dialysis. With a 30-day all-cause mortality of around 20% there is a high medical need for improved therapies for About acute bacterial skin and skin structure infections (ABSSSI) Acute bacterial skin and skin structure infections (ABSSSI) are common infections in healthcare settings. Staphylococcus aureus is the most common pathogen associated with these infections, which can be difficult to treat if methicillin-resistant Staphylococcus aureus (MRSA) is About community-acquired bacterial pneumonia (CABP) Community-acquired bacterial pneumonia (CABP) is a leading cause of morbidity and mortality worldwide. It is the leading cause of infectious disease-related death in the About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. Basilea is committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. Basilea has successfully launched two hospital brands, Cresemba (isavuconazonium sulfate), for the treatment of invasive fungal infections and ZEVTERA for the treatment of bacterial infections. In addition, the Company has preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics ("IST"), and a portfolio of strategic investments in healthcare assets. Innoviva's royalty portfolio includes respiratory assets partnered with Glaxo Group Limited ("GSK"). Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva's other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. On December 14, 2024, Innoviva entered into an exclusive distribution and license agreement with Basilea Pharmaceutica Ltd, Allschwil for the commercialization of ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. ZEVTERA® is a trademark of Basilea Pharmaceutica Ltd, Allschwil. ____________________ i Full US prescribing information: ii U.S. Food and Drug Administration. (2024, April 3). FDA approves new antibiotic for three different uses. [FDA News Release] iii Holland TL, Cosgrove SE, Doernberg SB, et al. Ceftobiprole for treatment of complicated Staphylococcus aureus bacteremia. N Engl J Med. 2023 Oct 12;389(15):1390-1401. iv Van der Vaart, Thomas; All-Cause and Infection-Related Mortality in Staphylococcus aureus Bacteremia, a Multicenter Prospective Cohort Study; Open Forum Infectious Diseases; December 2022, Volume 9, Issue 12; v Minejima, E., Mai, N., Bui, N., Mert, M., Mack, W. J., She, R. C., Nieberg, P., Spellberg, B., & Wong-Beringer, A. (2020). Defining the Breakpoint Duration of Staphylococcus aureus Bacteremia Predictive of Poor Outcomes. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 70(4), 566–573. vi K. Hamed, M. Engelhardt, M. E. Jones et al. Ceftobiprole versus daptomycin in Staphylococcus aureus bacteremia: a novel protocol for a double-blind, Phase III trial. Future Microbiology 2020 (1), 35-48 vii J. Edelsberg, C. Taneja, M. Zervos et al. Trends in US hospital admissions for skin and soft tissue infections. Emerging Infectious Diseases 2009 (15), 1516-1518 viii J. A. Ramirez, T. L. Wiemken, P. Peyrani et al. Adults hospitalized with pneumonia in the United States: Incidence, epidemiology, and mortality. Clinical Infectious Diseases 2017 (65), 1807-1812 View source version on Contacts Investors and Media: Innoviva, PattiCorporate Communications(908) Eleanor BarisserInvestor Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
15-03-2025
- Health
- Yahoo
Sacramento doctor: If not for NIH funding, I wouldn't have survived my leukemia diagnosis
Following a terminal leukemia/lymphoma diagnosis in 2010, my physicians estimated that I would live no more than five to eight years. Today, I am seven years past that expiration date and going strong. I can thank the investments in research made by the National Institutes of Health and other non-profit organizations — notably, the Leukemia & Lymphoma Society — which have allowed me to survive my leukemia. The current administration's threat to dramatically reduce or delay funding for the National Institutes of Health for many of the most talented researchers and clinicians in the best academic institutions in the nation represents a crushing blow not only to the development of future cancer therapies, but to all of medical research. Without previous funding, I would not be alive today. As a family physician, I opened my private practice in Sacramento in 1981, caring for patients from womb to tomb. My practice included obstetrics, pediatrics and adult care. This allowed me to experience the full spectrum of emotions that comes with medical work: the joy that comes with the arrival of a newborn, and the deep sadness of having to give a patient and their families the 'talk' regarding serious or fatal medical conditions. Opinion I self-diagnosed my own lymphoma. I was in shock and denial — as most people in my situation would be. From that day in 2010 until my treatment began in 2013, I continued my medical practice. When chemotherapy made it too risky for me to work in a medical office, I became the executive research director for the Leukemia & Lymphoma Society, blending my previous expertise into building a national database for blood cancer patients to study their outcomes. Since my first treatment in 2013, I have survived ten relapses, surgeries, radiation therapy and a dozen medical treatments, including six experimental therapies by way of clinical trials. Each and every one of the medications I have been given — ranging from conventional chemotherapy to targeted immunotherapy to an allogeneic bone marrow transplant — have been funded (at some point in their development) by the National Institutes of Health. These medications may not be household names, and may not be marketed by direct-to-consumer advertising, but they are lifesaving. My leukemia is not curable because the disease becomes resistant to the therapy given. It can be suppressed: Like playing whack-a-mole, it can be beaten down with the correct cadence of unique treatments by way of new drugs. When I required treatment in 2013, the only U.S. Food and Drug Administration-approved therapies were primarily conventional chemotherapy — a cocktail of drugs called Fludarabine, Cytoxan, Bendamustine and Rituximab, which required months of infusions. At that time, the targeted oral therapies and immunotherapies, which are available today, were only a glimmer in the eyes of doctors who treat the disease. Today, there are over a dozen FDA-approved therapies to treat my flavor of leukemia. Because I needed many of the drugs before they were approved, I opted to participate in clinical trials, where drugs are tested in the experimental phase prior to FDA approval. I am alive today because the National Institutes of Health and the U.S. research community have been able to produce modes of treatment about as quickly as my lymphoma morphed. Five of the clinical trials I entered have become FDA-approved therapies, including two rocket science-like therapies referred to as CAR T-cell therapy (treatments that involved taking my white blood T-cells, re-engineering them with inactive HIV and re-introducing them into my system to act as virtual Pac-Men tracking down and destroying leukemia cells). Research to develop CAR T-cell therapy began in the 1950s with the development of bone marrow transplant technology, taking a leap forward when genetic engineering helped to create the CAR T concept in the 1980s, with the first clinical trials in the 2010s. I am in debt to non-profit foundations that supported me and funded the incredible research that created new therapies for my leukemia. Philanthropic research funding and academic labs are successful because the National Institutes of Health spent billions of dollars for years to make sure that the U.S. research infrastructure supports innovation and progress. This infrastructure includes laboratory buildings and equipment, clinical trial access and expertise and scientists and care teams. I have lived the last 15 years believing that each therapy I was given represented a bridge to the next treatment. The longer the bridge, the better the chance there would be a new therapy waiting in the wings. My survival is based on research. With limited funding for the National Institutes of Health, I fear that my life and the lives of others in similar situations will be left with no hope. Medical research to treat life-threatening diseases has made incredible progress in the past few decades. A reduced investment today means reduced treatment options for far too many future cancer patients. Dr. Larry Saltzman practiced as a family physician in Sacramento and served as the president and CEO of Insurance Benefit Spot Check, Inc, a company he founded to simplify the complexities of healthcare coverage. He joined the Leukemia & Lymphoma Society as its executive research director to search for patterns of care that produce better outcomes with fewer side effects.
