Innoviva "announced that the FDA’s Antimicrobial Drugs Advisory Committee will convene April 17, 2023 to review data supporting the new drug application for sulbactam-durlobactam, or SUL-DUR. SUL-DUR is an investigational targeted antibiotic for the treatment of infections due to Acinetobacter baumannii-calcoaceticus complex. Infections caused by drug-resistant Acinetobacter are serious and life-threatening conditions associated with high morbidity and mortalityi. Carbapenem-resistant Acinetobacter is considered an urgent public health threat by the Centers for Disease Control and Prevention and a Priority 1 pathogen by the World Health Organization. The Committee will review data from studies involving SUL-DUR, including data from the landmark Phase 3 trial evaluating the safety and efficacy of SUL-DUR versus colistin in patients with infections caused by Acinetobacter. In the trial, 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. SUL-DUR also exhibited a favorable safety profile with lower incidence of nephrotoxicity compared to colistin."
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