FDA approves Xacduro for HABP and VABP caused by Acinetobacter infection
The FDA approved sulbactam and durlobactam (SUL+DUR; Xacduro, Innoviva Specialty Therapeutics) co-packaged for IV use to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of Acinetobacter baumannii–calcoaceticus complex
SUL+DUR is indicated for adults who are 18 years of age and older.
The FDA approval was based on data that included results from the landmark phase III, multicenter, active-controlled, open-label (investigator-unblinded, assessor-blinded) non-inferiority clinical ATTACK trial evaluating the safety and efficacy of SUL+DUR versus colistin in 177 hospitalized adults with pneumonia caused by carbapenem-resistant A. baumannii. Patients received either SUL+DUR or colistin 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 A. baumannii.
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 SUL+DUR, 19% (12/63 patients) died, compared with 32% (20/62 patients) who received colistin. SUL+DUR demonstrated statistical non-inferiority versus colistin for the primary end point of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections and a significant difference in clinical cure rates.
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