Flawed But Approvable? Crafting Appropriate Indication Looks To Be Focus Of Iterum’s Antibiotic AdComm

 
• By Sarah Karlin-Smith
  
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ES: A second pivotal study may be enough to get Iterum’s antibiotic through its second FDA review, but data gaps raise concerns about inappropriate prescribing contributing to antimicrobial resistance and could limit marketing differentiation.

Antibiotic stewardship will be a key topic at Iterum's UTI treatment advisory committee meeting. (Shutterstock)

The US Food and Drug Administration seems like it may be willing to clear [C#7765:Iterum Therapeutics plc]’s oral uncomplicated urinary tract infection (uUTI) treatment, if it can work out labeling that can guide physicians toward appropriate use that would minimize the threat of the product contributing to antimicrobial resistance or cross-resistance to other carbapenems.

Key Takeaways

  • The pivotal studies may be enough to get to a favorable benefit-risk balance, but not necessarily a label that leads to key marketing advantages such as use in patients who show signs of resistance to other uUTI treatments.

It doesn’t seem like any of the flaws FDA outlined in thepreview documentsfor sulopenem etzadroxil/probenecid’s 9 September Antimicrobial...

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