Iterum Therapeutics plc (NASDAQ: ITRM) has achieved FDA approval for Orlynvah (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. This approval is specifically for infections caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, where patients have limited or no alternative oral antibacterial treatment options. The approval marks a significant milestone for Iterum, representing its first FDA-approved product and the first approved indication for Orlynvah.
The FDA's decision was supported by a comprehensive clinical development program, including two Phase 3 clinical trials, SURE 1 and REASSURE. These trials evaluated the safety and efficacy of Orlynvah in comparison to existing treatments. SURE 1 demonstrated Orlynvah's superiority over ciprofloxacin in treating fluoroquinolone-resistant infections. REASSURE showed non-inferiority and statistical superiority to Augmentin in the Augmentin-susceptible population.
Clinical Trial Results
The SURE 1 trial's results highlighted Orlynvah's effectiveness against resistant strains, a growing concern in uUTI treatment. The REASSURE trial further solidified Orlynvah's position as a viable alternative, demonstrating its efficacy compared to a commonly used antibiotic. Full data sets from these trials will be presented at upcoming scientific conferences and publications.
Addressing Antimicrobial Resistance
Corey Fishman, Iterum’s CEO, stated, “The introduction of novel products, like Orlynvah, is an important way to combat antimicrobial resistance to other approved oral agents and offers a potential solution to patients and physicians.” This statement underscores the critical need for new treatment options in the face of increasing antibiotic resistance, particularly in community-acquired infections like uUTIs.
Michael Dunne, M.D., Chief Scientific Officer of Iterum, noted, “Multi-drug resistance in UTIs is alarmingly high and growing globally, and current treatment options are failing. In particular, resistance to fluoroquinolones continues to rise... The U.S. Food and Drug Administration (FDA) has recently strengthened existing warnings for the fluoroquinolone class and maintains that healthcare professionals should not prescribe fluoroquinolones to patients who have other treatment options for uUTI as the risks outweigh the benefits.”
Strategic Implications for Iterum
With this FDA approval, Iterum plans to pursue strategic transactions involving Orlynvah to maximize value for its stakeholders. As the first oral penem approved in the U.S., Orlynvah offers a valuable alternative in the underserved uUTI market.
Background on Complete Response Letter
It's important to note that the FDA previously issued a Complete Response Letter (CRL) in July 2021 regarding sulopenem etzadroxil/probenecid. The FDA requested additional data, including at least one more clinical trial and further non-clinical investigation to determine the optimal dosing regimen. Iterum addressed these concerns through subsequent trials and data submissions, leading to the current approval.
