Iterum Therapeutics announced that the U.S. FDA has approved its new drug application for sulopenem etzadroxil and probenecid, branded Orlynvah, for the treatment of uncomplicated urinary tract infections (uUTIs), marking the first FDA-approved product for the Dublin-based company.
The approval, which is specifically for uUTIs caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options, was based on two pivotal, phase 3 clinical trials (SURE 1 and REASSURE). In the SURE 1 trial, Orlynvah showed superiority to ciprofloxacin in fluoroquinolone resistant infections. In the second trial, REASSURE, Orlynvah showed non-inferiority and statistical superiority to USAntibiotics' Augmentin in the Augmentin susceptible population.
The second trial came at the behest of the FDA, who had handed Iterum a CRL back in July 2021. The agency had requested more data, specifically recommending that Iterum conduct at least one additional adequate and well-controlled clinical trial, potentially using a different comparator drug.
Orlynvah is taken as one oral tablet twice daily for five days. It's the first oral penem approved in the U.S.