Iterum Gains FDA Nod for Oral UTI Antibiotic, Pursues Asset Sale

Iterum Therapeutics has achieved a significant milestone with the FDA approval of its first product, Orlynvah. This oral antibiotic, a combination of sulopenem etzadroxil and probenecid, is now authorized for treating uncomplicated urinary tract infections (uUTIs) in adult women. Orlynvah is specifically indicated for cases involving three bacteria strains: Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis, particularly for patients with limited or no alternative oral antibiotic options.

Corey Fishman, Iterum’s CEO, described Orlynvah’s approval as a historic event that brings new hope to women dealing with difficult-to-treat uUTIs. He emphasized that Orlynvah, being the first oral penem approved in the U.S., provides a critical tool to combat antimicrobial resistance and represents a significant advancement for both patients and healthcare providers.

To ensure the successful market introduction of Orlynvah, Iterum plans to intensify efforts to find a strategic partner. Fishman highlighted the company's commitment to maximizing value for its stakeholders through renewed efforts in securing a strategic transaction for Orlynvah's commercialization.

The FDA’s decision was supported by robust clinical data from Iterum, including two Phase III trials. The pivotal REASSURE trial, with results released in January 2024, demonstrated that oral sulopenem is statistically non-inferior to Augmentin (amoxicillin/clavulanate) in terms of overall response. Orlynvah also showed higher overall treatment success compared to Augmentin, with both treatment groups exhibiting similar safety profiles.

Additional support came from the Phase III SURE 1 study conducted in June 2020, which highlighted that oral sulopenem was more effective than ciprofloxacin in patients with infections resistant to quinolones. This study also confirmed the safety of Orlynvah, as adverse events occurred at a comparable rate to those treated with ciprofloxacin.

Despite earlier setbacks, including a Complete Response Letter from the FDA in July 2021, Iterum persisted in its pursuit of approval. The letter had pointed out the need for an additional trial using a different comparator drug, despite evidence from SURE 1 establishing oral sulopenem’s superiority over ciprofloxacin.

Iterum resubmitted its application earlier this year, prompting the FDA to convene its Antimicrobial Drugs Advisory Committee. Although the panel did not vote on Orlynvah’s approvability, the discussion was promising. Fishman expressed optimism following the meeting, noting that the discussion recognized oral sulopenem as a vital treatment option for specific patients with uUTI.

With Orlynvah now approved, Iterum is poised to make a substantial impact in the field of uUTI treatment, offering new hope and an effective alternative for patients and physicians dealing with antibiotic-resistant infections.