Iterum Therapeutics plc ITRM recently announced updates from the meeting of the FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) that discussed its new drug application (NDA) for oral sulopenem for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women.

The FDA held the AMDAC meeting on Sept. 9, to discuss the overall benefits and risks of oral sulopenem in treating uUTIs in women aged more than 18 years and important factors for medical providers to know to ensure the proper use of sulopenem.

The FDA did not urge the AMDAC to vote on any matter.

Per some market reports, sulopenem's off-label use for treating uUTIs could be attached to a degree of high risk.

There are chances that sulopenem will be approved with certain limitations. In such a scenario, a post-marketing study would be imperative to confirm sulopenem’s proper use and label.

This might have hurt investors' sentiments and resulted in the stock going down 12% on Sept. 10 following the announcement of the news.

Shares of Iterum have plunged 51.8% so far this year compared with the industry’s decrease of 0.8%.

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Updates on ITRM’s NDA for Sulopenem

Iterum shared scientific evidence with the AMDAC, including data from two phase III studies, REASSURE and SURE-1, which evaluated sulopenem for the treatment of UTIs.

Per management, AMDAC acknowledged oral sulopenem as an important treatment option for patients with uUTI. It also agreed that physicians' appropriate use of oral sulopenem is critical to limiting antimicrobial resistance.

The FDA usually considers the AMDAC’s advice, but it is certainly not bound by the committee’s recommendations.

A decision from the FDA on whether or not to approve oral sulopenem as a treatment for uUTIs is due on Oct. 25, 2024.

If approved, sulopenem would become the first oral penem to be approved in the United States.

Earlier Setback Faced by ITRM

Sulopenem is an antibiotic developed to treat urinary tract and intra-abdominal infections.

We remind investors that in 2021, Iterum received a complete response letter (CRL) from the FDA against its initial NDA for oral sulopenem for the uUTIs indication. Per the CRL, the NDA could not be approved in its present form and additional data was required to support the approval of oral sulopenem for the treatment of adult women with uUTIs.

The FDA recommended Iterum to conduct an additional clinical study of the candidate, potentially using a different comparator drug.

The company resubmitted the oral sulopenem NDA for the uUTIs indication based on positive top-line results from the pivotal REASSURE study, which was announced in January 2024.