Flawed But Approvable? Crafting Indication Possible Focus Of Iterum’s Antibiotic AdComm

A second pivotal study may be enough to push Iterum’s antibiotic through its second FDA review, but data gaps raised concerns about inappropriate prescribing contributing to antimicrobial resistance and could limit marketing differentiation.

close up of person grasping pelvic area in pain — Antibiotic stewardship will be a key topic at Iterum's UTI treatment advisory committee meeting. • Source: Shutterstock

The US Food and Drug Administration may be willing to clear Iterum Therapeutics plc’s oral uncomplicated urinary tract infection (uUTI) treatment, if labeling can be written to guide physicians toward appropriate use and minimize the threat of antimicrobial resistance or cross-resistance to other carbapenems.

Key Takeaways

Iterum’s pivotal studies may be enough for a favorable benefit-risk balance, but not necessarily a label that offers key marketing advantages, such as use in patients who show signs of resistance to other uUTI treatments.

None of the flaws FDA outlined in the preview documents for sulopenem etzadroxil/probenecid's 9 September Antimicrobial Drugs Advisory Committee...