Iterum says FDA is in 'general alignment' on proposed new PhIII for rejected uUTI drug
Iterum Therapeutics is painting a rosier picture of its once-rejected antibiotic after meeting with the FDA last week.
The agency was in “general alignment” with the Dublin and Chicago-based biotech after discussing a proposed additional Phase III clinical study of sulopenem for uncomplicated urinary tract infections, or uUTI, Iterum said Wednesday.
Next up is an agreement request with the regulator for a special protocol assessment of the clinical trial, which will be a non-inferiority study comparing Iterum’s oral drug to amoxicillin clavulanate, an antibiotic once involved in a legal dispute between GlaxoSmithKline and Novartis over generics production, in adult women.
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