Iterum Therapeutics plc (NASDAQ: ITRM) has announced that the FDA has issued it with a Complete Response Letter for its NDA for oral sulopenem (sulopenem etzadroxil/probenecid). According to the CRL, the FDA has finalized the NDA review and established that it could not approve it as it is.
Iterum should conduct more clinical studies in sulopenem
The FDA noted in the CRL that the Phase 3 SURE-1 clinical study found statistical significance in oral sulopenem’s overall response rate difference versus ciprofloxacin in ciprofloxacin-resistant patients. However, the FDA established that more data is needed to support approval for uncomplicated urinary tract infection treatment in adult women caused by specified susceptible bacteria proven or highly believed to be non-quinolone resistant.
Also, the FDA recommended that Iterum should conduct another well-controlled and sufficient clinical trial, possibly with a different comparator medication. The FDA equally advised that the company performs additional nonclinical research to determine the best dosing schedule. However, according to the FDA, the recommendation does not pose an approvability concern. The FDA stated that it is willing to collaborate with the company on the clinical trial to solve the cited flaws. Most importantly, the CRL didn’t identify any CMC or safety issues in more than 1,800 patients who received sulopenem.
Iterum to hold Type Q meeting with FDA
Chief executive officer Corey Fishman said, “We are disappointed in this outcome and believe that the data package submitted was adequate for the approval of oral sulopenem. 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.”
Iterum plans to evaluate the CRL with its advisors and requests a Type A meeting within the next few weeks. The company will offer an update following the Type A meeting.
