Iterum provides update on FDA advisory committee discussion on oral sulopenem

Iterum Therapeutics announced that a meeting of the U.S. Food and Drug Administration’s Antimicrobial Drugs Advisory Committee took place on September 9, 2024 at which Iterum’s new drug application for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in adult women was discussed. Specifically, the FDA convened the AMDAC meeting to discuss the overall benefits and risks for the use of sulopenem etzadroxil/probenecid for the treatment of uUTI caused by designated susceptible microorganisms in adult women greater than 18 years of age, andconsiderations that would be important for medical providers to know to ensure appropriate use of sulopenem etzadroxil/probenecid. The FDA did not ask the AMDAC to vote on any matter. The AMDAC was provided scientific evidence shared by Iterum, including data from the pivotal REASSURE Phase 3 clinical trial, and data from the SURE-1 Phase 3 clinical trial. The FDA is not bound by the recommendations of the AMDAC but takes its advice into consideration. The FDA’s decision on whether or not to approve oral sulopenem for the treatment of uUTIs in adult women is expected by the Prescription Drug User Fee Act goal date of October 25, 2024.