FDA Grants approval for Xacdura for treatment of ventilator associated bacterial pneumonia
Type of article: News
MedED Catalogue Reference: MCEND002
Category: News | Infectious Diseases
Category Tags: hospital-acquired bacterial pneumonia, HABP, ventilator-associated bacterial pneumonia, VABP, Acinetobacter, antimicrobial resistance, AMR
Source: Syndax Pharmaceuticals, Press Release 24 July 23
The U.S. Food and Drug Administration (FDA) has approved Xacduro (sulbactam for injection; durlobactam for injection) as a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of the Acinetobacter baumannii-calcoaceticus complex in patients aged 18 years and older. Acinetobacter species are considered critical bacterial pathogens posing a significant threat to human health due to growing global resistance to antimicrobial medicines.
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 to Xacduro was liver function test abnormalities.
The FDA granted Xacduro Fast Track, Qualified Infectious Disease Product, and Priority Review designations for this application. The approval was granted to Entasis Therapeutics.
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FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria 
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