XACDURO, The First And Only Antibiotic Developed To Target Acinetobacter, Now Available To Treat Hospital-Acquired Bacterial Pneumonia And Ventilator-Associated Bacterial Pneumonia In Adults

Author: Benzinga Newsdesk | September 18, 2023 08:01am

• XACDURO is a new FDA-approved treatment used to fight against HABP/VABP infections caused by isolates of Acinetobacter baumannii-calcoaceticus complex, which can include those resistant to carbapenems (CRAB).
• In the U.S., it is estimated there are more than 40,000 cases of Acinetobacter each year and approximately 40 percent are carbapenem-resistant.1,2
• Patients with HABP/VABP caused by Acinetobacter infections face high mortality and significant costs due to drug resistance and limited approved treatment options.

Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (NASDAQ:INVA), today announced that XACDURO® (sulbactam for injection; durlobactam for injection) is now available in the United States for patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter).

"XACDURO's pathogen-targeted approach is a significant advancement in the way healthcare professionals treat Acinetobacter, one of the most serious antibiotic-resistant pathogens known to cause life-threatening pneumonia that is associated with high morbidity and mortality rates," said Pavel Raifeld, Chief Executive Officer, Innoviva. "The addition of XACDURO to our portfolio of critical care medicines underscores our commitment to this space by providing healthcare professionals with differentiated therapeutic options to help improve patient outcomes."

XACDURO received regulatory approval from the U.S. Food and Drug Administration (FDA) in May 2023 and is now available by prescription through specialty pharmacy distributors in a healthcare setting. The FDA approval was based on strong scientific evidence, including results from the landmark Phase 3 ATTACK trial, published in The Lancet: Infectious Disease, evaluating the safety and efficacy of XACDURO versus colistin in patients with infections caused by Acinetobacter.3 In the trial, XACDURO demonstrated statistical non-inferiority versus colistin for the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections and a significant difference in clinical cure rates.3 XACDURO was well tolerated and exhibited a favorable safety profile across the clinical program. In clinical studies, XACDURO was shown to significantly lower the incidence of nephrotoxicity.3 Fewer serious adverse events were observed compared to treatment with colistin, and there was lower treatment discontinuation due to adverse reactions versus colistin with one patient experiencing anaphylactic shock, which lead to discontinuation of treatment for that patient.3

Acinetobacter infections are now the fifth most common cause of deaths attributable to drug resistance across the globe and pose greatest threat to patients on ventilators in hospitals and nursing homes. The Acinetobacter pathogen has become resistant to most antibiotics used to treat HABP and VABP including carbapenems and third generation cephalosporins. This has caused Acinetobacter tobecomeincreasingly difficult to treat with no clear standard of care antibiotic regimen for these resistant infections.

"Every minute matters when managing critical care patients with life-threatening pneumonia, especially when caused by carbapenem-resistant Acinetobacter baumannii pathogen. Antibiotic-resistant pathogens can complicate treatment strategies and compromise treatment efficacy, often resulting in increased mortality rates for intensive care unit patients," said Margaret Koziel, MD, Chief Medical Officer, Innoviva. "Other treatment options may have high rates of resistance and adverse events, including nephrotoxicity.4 The availability of XACDURO is a much-needed advancement that can now provide healthcare professionals with an innovative therapy option to safely and effectively manage Acinetobacter pneumonia."

About Acinetobacter

Members of theAcinetobacter baumannii-calcoaceticus complex (Acinetobacter) are Gram-negative, opportunistic human pathogens that predominantly infect critically ill patients, often resulting in severe pneumonia and bloodstream infections.5 They can infect other body sites, such as the urinary tract and the skin.5 Acinetobacter is considered a global threat in the healthcare setting due in part to its ability to acquire multidrug resistance.6 Acinetobacter is resistant to penicillins and has also acquired resistance genes for almost all antibiotics used to treat Gram-negative bacteria, including fluoroquinolones, aminoglycosides, cephalosporins, and carbapenems.6

The Centers for Disease Control and Prevention (CDC) has identified carbapenem-resistant micro-organisms as an urgent threat.7 Globally, Acinetobacter baumannii was among the top six leading pathogens for deaths associated with resistance in 2019.8Carbapenem-resistant Acinetobacter is considered a Priority 1 pathogen by the World Health Organization (WHO).9 Globally, there are about a million cases each year of Acinetobacter, and about two-thirds of those are carbapenem-resistant Acinetobacter baumannii.1 More than 300,000 global deaths annually are associated with carbapenem-resistant Acinetobacter.8

About XACDURO®

XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use, is a combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor, approved in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). XACDURO is not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter.

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