Iterum Therapeutics Announces FDA Advisory Committee Meeting to discuss NDA for Oral Sulopenem for the treatment of Uncomplicated Urinary Tract Infections
DUBLIN, Ireland and CHICAGO, June 21, 2024 (GLOBE NEWSWIRE) — Iterum Therapeutics plc (Nasdaq:ITRM) (the Company), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that the U.S. Food and Drug Administration (FDA) has determined that the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women will be taken to Advisory Committee, and in its communication, highlighted that the purpose of the Advisory Committee was to discuss a) antimicrobial stewardship issues raised by potential approval and subsequent use of what would be the first oral penem in the U.S.; and b) the most appropriate target patient population(s) for treatment of uUTI with sulopenem etzadroxil/probenecid. The proposed date for the Advisory Committee meeting is September 9, 2024.