Iterum announces FDA advisory committee meeting for oral sulopenem NDA

Iterum Therapeutics announced that the U.S. Food and Drug Administration has determined that the New Drug Application for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in adult women will be taken to Advisory Committee, and in its communication, highlighted that the purpose of the Advisory Committee was to discuss antimicrobial stewardship issues raised by potential approval and subsequent use of what would be the first oral penem in the U.S.; and the most appropriate target patient population for treatment of uUTI with sulopenem etzadroxil/probenecid. The proposed date for the Advisory Committee meeting is September 9, 2024. In April 2024, the Company announced that it had resubmitted its NDA to the FDA for oral sulopenem for the treatment of uUTIs in adult women. In May 2024, the FDA acknowledged receipt of the resubmission of the NDA. Under the Prescription Drug User Fee Act, the FDA deemed the Company’s NDA resubmission to be a Class II complete response which has a six-month review period from the date of resubmission. As a result, the FDA has assigned a PDUFA action date of October 25, 2024.