Iterum Therapeutics plc

Complete Response Letter (CRL)

Iterum discloses that it received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem). The CRL provides that the FDA has completed its review of the NDA and has determined that it cannot approve the NDA in its present form.

“In the CRL, the FDA acknowledged that the Phase 3 SURE-1 clinical trial demonstrated statistical significance in difference in overall response rate of oral sulopenem compared to ciprofloxacin in the ciprofloxacin-resistant population. However, the FDA determined that additional data are necessary to support approval for the treatment of adult women with uncomplicated urinary tract infections caused by designated susceptible microorganisms proven or strongly suspected to be non-susceptible to a quinolone. The FDA recommended that Iterum conduct at least one additional adequate and well-controlled clinical trial, potentially using a different comparator drug. Additionally, the FDA recommended that Iterum conduct further nonclinical investigation to determine the optimal dosing regimen, although the FDA stated that this recommendation does not raise an approvability issue.“

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