Iterum announces FDA acceptance of resubmission of oral sulopenem NDA

Iterum Therapeutics announced that the U.S. Food and Drug Administration has acknowledged receipt of the resubmission of the New Drug Application for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in adult women. Under the Prescription Drug User Fee Act, the FDA has 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. The resubmission includes additional evidence from the REASSURE clinical trial, conducted under Special Protocol Assessment agreement from the FDA, comparing oral sulopenem to oral Augmentin in adult women with a uUTI, demonstrated that oral sulopenem was non-inferior to Augmentin for the primary efficacy endpoint of clinical and microbiologic response at the test-of-cure visit for patients with an Augmentin susceptible pathogen, with the difference in the overall success rate demonstrating statistically significant superiority of oral sulopenem versus Augmentin.