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- Shares of Iterum Therapeutics (NASDAQ:ITRM) fell 9% Tuesday, the day after an FDA advisory committee met to discuss the company’s resubmitted application for oral sulopenem for the treatment of uncomplicated urinary tract infections, or UTIs, in adult women.
- In a statement released Tuesday, Iterum said it will continue to work with the FDA on the review of the application and potential labeling for the product. The FDA’s target action date is Oct. 25.
- During the advisory committee meeting on Monday, panelists acknowledged that the treatment would be beneficial for a subset of patients with uncomplicated UTIs. However, the panel also discussed what limitations or instructions would need to be included in the product’s labeling to help prevent inappropriate use and limit antimicrobial resistance.
- The FDA declined to approve oral sulopenem in 2021, citing the need for additional clinical trial. Iterum resubmitted the application in April.
