Grandbrothers/iStock Editorial via Getty Images Iterum Therapeutics ( NASDAQ: ITRM ) announced Friday that the U.S. Food and Drug Administration (FDA) has convened an advisory committee meeting as part of an ongoing review of the company’s new drug application (NDA) for its lead asset, oral sulopenem.
In 2021, the FDA declined to approve the anti-infective compound for uncomplicated urinary tract infections (uUTIs) in adult women, citing a requirement for additional data. The Dublin, Ireland-based pharma resubmitted the NDA in April, and the regulator accepted it for review a month later, granting October 25, 2024, as the target action date. In its notice about the upcoming meeting, the regulator has detailed the subjects the panel is expected to consider, including matters regarding the most eligible patient group for the therapy, also known as sulopenem etzadroxil/probenecid.
The AdCom meeting is scheduled for September 9, 2024. More on Iterum Therapeutics Iterum Therapeutics plc (ITRM) Q1 2024 Earnings Call Transcript Iterum Therapeutics plc (ITRM) Q4 2023 Earnings Call Transcript Iterum Therapeutics Non-GAAP EPS of -$0.38 beats by $0.
16 Iterum Therapeutics resubmits new drug application to U.S. FDA for oral sulopenem Seeking Alpha’s Quant Rating on Iterum Therapeutics.
