FDA Raises Concerns Over Inappropriate Use of Iterum’s Antibiotic Ahead of Advisory Committee Meeting

FDA Concerns:
The FDA has raised concerns about the potential inappropriate use of Iterum's oral antibiotic, sulopenem etzadroxil/probenecid, for uncomplicated urinary tract infections (uUTIs), citing antimicrobial resistance issues.

Advisory Committee Meeting:
An FDA advisory committee meeting is scheduled for September 9, 2024, to discuss the New Drug Application (NDA) for sulopenem etzadroxil/probenecid, focusing on antimicrobial stewardship and the appropriate target patient population.

Previous Rejection:
In 2021, the FDA rejected Iterum's initial application for sulopenem, requesting additional data from at least one more trial, potentially using a different comparator drug.

Resubmission:
Iterum resubmitted its NDA in April 2024, with the FDA assigning a PDUFA action date of October 25, 2024.

Antimicrobial Resistance:
The FDA's concerns highlight the broader issue of antimicrobial resistance, emphasizing the need for judicious use of antibiotics to prevent the development of resistant bacteria.