FDA Advisory Committee review for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections

Specifically, the FDA convened the AMDAC meeting to discuss a) the overall benefits and risks for the use of sulopenem etzadroxil/probenecid for the treatment of uUTI caused by designated susceptible microorganisms in adult women  greater than 18 years of age, and b) considerations that would be important for medical providers to know to ensure appropriate use of sulopenem etzadroxil/probenecid. The FDA did not ask the AMDAC to vote on any matter.

“We are encouraged by the AMDAC’s discussion which acknowledged oral sulopenem as an important treatment option for certain patients with uUTI and agree that the appropriate use of oral sulopenem by treating physicians is critical to limiting antimicrobial resistance,” said Corey Fishman, Iterum’s Chief Executive Officer. “We look forward to continuing to work with the FDA on the review of the NDA and potential labeling over the next few months.”