Innoviva, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the new drug application (NDA) for SUL-DUR, an investigational drug for the treatment of infections caused by Acinetobacter baumannii-calcoaceticus complex (ABC), including multi-drug resistant and carbapenem-resistant strains. The Agency is currently planning to hold an advisory committee meeting to discuss this application. The target PDUFA date (or action date) is May 29, 2023.

The NDA submission is based on results from the landmark Phase 3 ATTACK trial evaluating the safety and efficacy of SUL-DUR versus colistin in patients with infections caused by ABC. 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 ABCinfections and a significant difference in clinical cure rates. SUL-DUR also exhibited a favorable safety profile with statistically significant reduction in nephrotoxicity.