By Marie Rosenthal, MS
Although the FDA asked the Antimicrobial Drugs Advisory Committee (AMDAC) to discuss sulopenem etzadroxil/probenecid (oral sulopenem, Iterum Therapeutics) as an option to treat uncomplicated urinary tract infections (uUTIs), the agency did not ask the panel to vote on a recommendation.
Still, the panel had plenty to say. While acknowledging the need for a safe, oral option to treat UTI, there was concern that oral sulopenem would be used off-label, and this would drive