Drugs Xagena
The U.S. Food and Drug Administration has approved Xacduro ( Sulbactam for injection; Durlobactam for 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 - Acinetobacter 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 global resistance to antimicrobial medicines.
Acinetobacter baumannii-calcoaceticus complex ( also known as A. baumannii ) includes four species of bacteria in the Acinetobacter family. These bacteria can cause infections in various parts of the body, occurring most frequently in healthcare settings and predominantly causing pneumonia. A. baumannii can become highly resistant to multiple antibacterial drugs and current treatment options for drug-resistant A. baumannii are limited.
Xacduro consists of Sulbactam, a drug structurally related to Penicillin, and Durlobactam. Sulbactam kills A. baumannii whereas Durlobactam protects Sulbactam from being degraded by enzymes that may be produced by A. baumannii.
Xacduro is administered by intravenous infusion.
Xacduro’s efficacy was established in a multicenter, active-controlled, open-label ( investigator-unblinded, assessor-blinded ), non-inferiority clinical trial in 177 hospitalized adults with pneumonia caused by carbapenem-resistant A. baumannii. Patients received either Xacduro or Colistin ( a comparator antibiotic ) for up to 14 days. Both treatment arms also received an additional antibiotic, Imipenem / Cilastatin, as background therapy for potential HABP/VABP pathogens other than Acinetobacter baumannii-calcoaceticus complex.
The primary measure of efficacy was mortality from all causes within 28 days of treatment in patients with a confirmed infection with carbapenem-resistant A. baumannii.
Of those who received Xacduro, 19% ( 12 of 63 patients ) died, compared to 32% ( 20 of 62 patients ) who received Colistin; this demonstrated that Xacduro was noninferior 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 Clostridioides, difficile-associated diarrhea.
Patients should not receive Xacduro if they have a history of known severe hypersensitivity to components of Xacduro, Sulbactam or other beta-lactam antibacterial drugs. ( Xagena )
Source: FDA, 2023
XagenaMedicine_2023
