Iterum Gets Complete Response Letter from FDA for Oral Sulopenem

 Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced 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) on July 23, 2021. The CRL provided 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. The FDA indicated its willingness to work with Iterum on the design of the clinical trial(s) to address the deficiencies noted.

There were no chemistry, manufacturing or controls (CMC) issues identified in the CRL, nor were there any safety issues found in over 1,800 patients treated with sulopenem across the Company’s clinical development program.

“We are disappointed in this outcome and believe that the data package submitted was adequate for the approval of oral sulopenem,” said Corey Fishman, Chief Executive Officer. “Regardless, we will evaluate the points raised in the CRL for discussion with the FDA to determine an expeditious path forward. We remain confident in the value of, and unmet medical need for, oral sulopenem to treat multi-drug resistant infections, including fast-growing quinolone non-susceptible pathogens.”

https://finance.yahoo.com/news/iterum-therapeutics-receives-complete-response-110000115.html