Iterum Therapeutics resubmits NDA to U.S. FDA for oral sulopenem

Iterum Therapeutics announced that it has resubmitted its New Drug Application, NDA, to the U.S. Food and Drug Administration, FDA, for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in adult women. “The resubmission of the NDA filing for oral sulopenem is a significant step forward in bringing a new antibiotic to the market for women that suffer from an estimated 40 million uUTIs each year in the U.S.,” said Corey Fishman, Chief Executive Officer. “The availability of oral sulopenem, if approved, would mean that physicians and patients have the opportunity to benefit from the proven efficacy and safety of penem antibiotics that, to date in the U.S., have only been available in IV formulations. We look forward to working with the FDA through the review process to advance this much needed treatment option.”