Sulopenem

FDA advisory committee raises concerns over antibiotic resistance and inappropriate use of sulopenem for uUTIs in adult women, emphasizing the need for appropriate use guidelines and potential modifications to drug labeling to mitigate risks.

Iterum Therapeutics discussed its NDA for oral sulopenem, a treatment for uUTI in adult women, with the FDA's AMDAC on Sept. 9, 2024. The committee reviewed the drug's benefits, risks, and appropriate use, with no voting held. Iterum awaits FDA approval by the PDUFA goal date of Oct. 25, 2024.

H.C. Wainwright's Ed Arce maintains Buy rating on Iterum Therapeutics (ITRM) due to sulopenem's potential approval for uUTIs in adult women, despite AMR concerns. The Antimicrobial Drugs Advisory Committee supports a restrictive label to limit off-label use, emphasizing sulopenem's benefits in specific populations and its role against ESBL-producing organisms. The FDA's expected approval, with potential limitations, bolsters Iterum's market position.

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.

FDA reviewers express concerns over the benefits vs. risks of sulopenem etzadroxil/probenecid, a novel oral antibiotic for uncomplicated urinary tract infections (uUTIs), ahead of an advisory committee meeting. The drug, with activity against gram-positive, gram-negative, and anaerobic organisms, was rejected in 2021 but resubmitted by Iterum Therapeutics in April after another phase III trial. The new trial data showed non-inferiority to amoxicillin/clavulanate but had a small sample size of resistant organisms, raising efficacy questions. The FDA warns of potential inappropriate use and antimicrobial resistance (AMR) risks, emphasizing the need for careful stewardship and guideline considerations.

Iterum Therapeutics' NDA resubmission for oral sulopenem to treat uncomplicated urinary tract infections in adult women is accepted by the FDA, with a PDUFA action date of October 25, 2024.

Iterum Therapeutics resubmits NDA to FDA for oral sulopenem to treat uncomplicated urinary tract infections in adult women, with data from phase 3 clinical trials demonstrating its efficacy and safety.