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

 
• By Sarah Karlin-Smith

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

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