Innoviva, Inc. announced that the U.S. Food and Drug Administration's (FDA) Antimicrobial Drugs Advisory Committee will convene April 17, 2023 to review data supporting the new drug application (NDA) for sulbactam-durlobactam (SUL-DUR). SUL-DUR is an investigational targeted antibiotic for the treatment of infections due to Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). 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 (CDC)ii and a Priority 1 pathogen by the World Health Organization (WHO)iii. 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. The SUL-DUR NDA, filed on September 29, 2022 by Entasis Therapeutics Inc., a wholly owned subsidiary of Innoviva, is currently under Priority Review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2023.