FDA Advisors Seek Narrower Indication for Iterum’s Oral Sulopenem in Treating Uncomplicated Urinary Tract Infections

FDA Advisory Committee Meeting:
The FDA's Antimicrobial Drugs Advisory Committee (AMDAC) met on September 9, 2024, to discuss Iterum Therapeutics' new drug application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for treating uncomplicated urinary tract infections (uUTIs) in adult women.

Concerns Over Indication:
The committee raised concerns about whether the proposed indication for oral sulopenem is restrictive enough, suggesting a more limited indication to address antimicrobial resistance issues.

Clinical Trials:
The discussion included data from the pivotal REASSURE and SURE-1 Phase 3 clinical trials, which demonstrated the efficacy and safety of oral sulopenem in treating uUTIs caused by resistant pathogens.

Antimicrobial Resistance:
The treatment of UTIs has become more challenging due to the development of resistance by pathogens responsible for these infections. Approximately 30% of uUTIs are caused by quinolone non-susceptible organisms, and about 1% are caused by pathogens resistant to all commonly available classes of oral antibiotics.

PDUFA Goal Date:
The FDA's decision on whether to approve oral sulopenem for the treatment of uUTIs in adult women is expected by the Prescription Drug User Fee Act (PDUFA) goal date of October 25, 2024.