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US FDA Advisors Want Iterum’s Antibiotic Indication Narrowed

 
• By Sarah Karlin-Smith

The agency’s Antimicrobial Drugs Advisory Committee suggested a more limited indication for Interum’s antibiotic for uncomplicated urinary tract infections than the sponsor proposed, though it wasn’t necessarily clear committee members favored approval.

Sulopenem advisory committee meeting
The FDA held the first fully in-person advisory committee since the emergence of COVID-19 on 9 September at its Maryland headquarters. • Source: Sarah Karlin-Smith

Iterum Therapeutics plc’s oral antibiotic sulopenem etzadroxil/probenecid for uncomplicated urinary tract infections could be headed for US Food and Drug Administration approval, albeit with a much narrower label than proposed before the 9 September Antimicrobial Drugs Advisory Committee meeting.

Key Takeaways

  • Though no formal vote was taken, the FDA’s Antimicrobial Drugs Advisory Committee did not appear to support Iterum's uUTI antibiotic approval with the proposed labeling.

  • The committee was open to a narrower indication, but was not confident it would be followed in practice

Iterum is seeking an indication in adult women for the treatment of uncomplicated urinary tract infection (uUTI) caused

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