FDA Denies NDA for Iterum Therapeutics Oral Sulopenem


The company will review the CRL and request a Type A meeting in the coming weeks.

On Monday, Iterum Therapeutics announced that they had received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem).

Iterum Therapeutics is 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 and is based in Dublin, Ireland.

In the CRL, the FDA stated that they had completed their review of the NDA and determined that they cannot approve the NDA in its present form.

The FDA acknowledged in the CRL that the phase 3 SURE-1 trial demonstrated statistical significance in difference in overall response rate of oral sulopenem compared to ciprofloxacin in the ciprofloxacin-resistant population.

However, it was determined that additional data would be necessary for them 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.

For full approval to be granted, the FDA recommended the company conduct at least 1 additional clinical trial, potentially using a different comparator drug.

No chemistry, manufacturing or control (CMC) issues were identified in the CRL, and no safety issues were found in over 1,800 patients treated with the therapy.

Iterum plans on reviewing the CRL and intends on requesting a Type A meeting in the coming weeks.

“We are disappointed in this outcome and believe that the data package submitted was adequate for the approval of oral sulopenem,” Corey Fishman, chief executive officer at Iterum said. “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.”

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