Advisory committee meeting for oral sulopenem occurring September 9, 2024

pharmaceutical-technology.com

Iterum Therapeutics' oral sulopenem faces FDA approval for uUTIs, with concerns over antibiotic resistance. The drug, a thiopenem antibiotic, previously faced rejection due to insufficient evidence. A Phase III trial showed efficacy in 61.7% of patients, leading to an NDA resubmission. The FDA's PDUFA date is October 25. The approval hinges on responsible use to prevent resistance.

contemporaryobgyn.net

Advisory committee meeting on September 9, 2024, to discuss the NDA for oral sulopenem tablets, developed by Iterum Therapeutics to treat UTIs in women. The REASSURE trial demonstrated non-inferiority of sulopenem compared to Augmentin, with a similar safety profile and no new safety signals except those linked to β-lactams. The FDA accepted the resubmitted NDA with a PDUFA action date of October 25, 2024.

stocktitan.net

Iterum Therapeutics provided an update on the FDA Advisory Committee discussion of oral sulopenem for treating uUTI in adult women. The AMDAC acknowledged oral sulopenem as an important treatment option. Iterum presented data from the REASSURE and SURE-1 Phase 3 clinical trials. The FDA's decision on approval is expected by the PDUFA goal date of October 25, 2024. If approved, oral sulopenem could become the first oral penem approved in the U.S., offering a new treatment for multi-drug resistant pathogens.

urologytimes.com

The FDA Antimicrobial Drugs Advisory Committee discusses the NDA for oral sulopenem for treating uUTI in adults, addressing antimicrobial stewardship and target patient populations. The PDUFA date is October 25, 2024. Oral sulopenem shows superiority in treating uUTI caused by resistant bacteria, with a need for new, safe, and effective treatment options due to rising AMR rates.