US Advisory Committees
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
Recent ODACs suggest FDA is moving towards focusing not just on applications with pending approval decisions but on refining trials designs and drug labels for their competitors as well.
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.