25 January 2021 - If approved, first oral penem in the U.S. and first new oral treatment for uUTIs in over 20 years.

Iterum Therapeutics today announced that the U.S. FDA accepted for review the new drug application for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in patients with a quinolone non-susceptible pathogen. 

The FDA has designated this application as a priority review and consequently assigned a PDUFA goal date for completion of the review of oral sulopenem of 25 July 2021.

The agency currently plans to hold an advisory committee meeting to discuss the new drug application.

Read Iterum Therapeutics press release