Thursday, May 25, 2023
The US Food and Drug Administration (FDA) has approved Xacduro (sulbactam injection; durlobactam injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for patients 18 years of age and older.
According to the World Health Organization, Acinetobacter species top the list of critical bacterial pathogens that pose the greatest threat to human health, highlighting the high level of need for additional treatment options amid growing resistance. global access to antimicrobial drugs.
"The FDA is dedicated to supporting the development of safe and effective treatment options for infections caused by hard-to-fight bacteria such as Acinetobacter baumannii-calcoaceticus complex ," said Peter Kim , MD , director of the Division of Anti-infectives at the Center for FDA Drug Evaluation and Research. "Today's approval helps address a large unmet medical need by providing an additional treatment option for some of the sickest patients in our nation's hospitals."
The Acinetobacter baumannii-calcoaceticus complex (hereinafter referred to as A. baumannii ) includes four species of bacteria from the Acinetobacter family . These bacteria can cause infections in various parts of the body, most often occurring in healthcare settings and mainly causing pneumonia. A. baumannii can become highly resistant to multiple antibacterial drugs, and current treatment options for drug-resistant A. baumannii are limited.
Xacduro is made up of sulbactam, a drug structurally related to penicillin, and durlobactam. Sulbactam kills A. baumannii , while durlobactam protects sulbactam from degradation by enzymes that A. baumannii may produce . Xacduro is administered by intravenous infusion.
The efficacy of Xacduro was established in a multicenter, active-controlled, open-label (investigator unblinded, assessor blinded), non-inferiority clinical study in 177 adults hospitalized with carbapenem-resistant A. baumannii pneumonia . Patients received Xacduro or colistin (a comparator antibiotic) for up to 14 days. Both treatment groups also received an additional antibiotic, imipenem or cilastatin, as background therapy for possible HABP or VABP pathogens other than Acinetobacter baumannii-calcoaceticus complex . The primary measure of efficacy was all-cause mortality within 28 days of treatment in patients with confirmed infection withA. baumannii resistant to carbapenem. Of the patients who received Xacduro, 19% (12 of 63 patients) died, compared to 32% (20 of 62 patients) who received colistin. This demonstrated that Xacduro was not inferior to colistin.
The most common adverse reaction with Xacduro was liver function test abnormalities. Xacduro comes with certain warnings and precautions, such as hypersensitivity reactions and diarrhea associated with Clostridiodes difficile.
Patients should not receive Xacduro if they have a history of known severe hypersensitivity to the components of Xacduro, sulbactam or other beta-lactam antibacterial medicinal products.