Drugs

Committee to Consider Iterum Sulopenem NDA

The FDA Antimicrobial Drugs Advisory Committee will consider 9/9 a resubmitted Iterum Therapeutics NDA for sulopenem etzadroxil/probenecid, an oral treatment for uncomplicated urinary tract infections caused by designated susceptible bacteria in adult women. An agency briefing document released in advance of the meeting says the committee is to discuss whether the overall benefit/risk assessment is favorable for using sulopenem etzadroxil/probenecid for the indication being sought and to consider the information that would be most important to convey to medical providers to ensure appropriate use of the drug.

The company’s initial 2020 NDA submission drew a 7/23/2021 complete response letter from FDA due to a lack of substantial evidence of effectiveness. The company was advised to conduct another trial and conduct further investigation into the optimal dosing.

The briefing document says Iterum decided at that point to stop developing IV sulopenem and focus on oral sulopenem etzadroxil/probenecid. It conducted an additional trial in which the drug met its primary endpoint of overall response, FDA says.

Committee members are asked (1) whether the overall benefit/risk assessment is favorable for the proposed indication and (2) what considerations would be important to convey to medical providers to ensure appropriate use of the product.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome