## Iterum Therapeutics Scores FDA Approval for Orlynvah to Treat Uncomplicated UTIs in Women
In a significant victory for Iterum Therapeutics plc (ITRM), the company’s Orlynvah (sulopenem etzadroxil and probenecid) has received FDA approval for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. This marks a crucial milestone for Iterum, as it represents the first FDA-approved product for the company and the first approved indication for Orlynvah.
Orlynvah’s path to approval was paved by a robust clinical development program, including two pivotal Phase 3 clinical trials (SURE 1 and REASSURE). These trials rigorously assessed the safety and efficacy of Orlynvah compared to established treatments like ciprofloxacin and Augmentin. The results were encouraging: SURE 1 demonstrated superiority to ciprofloxacin in treating fluoroquinolone-resistant infections, while REASSURE showcased non-inferiority and even statistical superiority to Augmentin in the Augmentin susceptible population.
The significance of this approval extends beyond Iterum’s success. The emergence of antibiotic resistance is a growing global health concern, and the introduction of novel products like Orlynvah is a critical step in combating this threat. As Corey Fishman, Iterum’s CEO, aptly states, “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.”
Orlynvah’s approval as the first oral penem in the U.S. provides a much-needed alternative treatment option for women with uUTIs, particularly those who have limited or no alternative oral antibacterial treatment options. With FDA approval and a clear label, Iterum is committed to maximizing value for its stakeholders by pursuing strategic transactions involving Orlynvah.
This achievement is a testament to Iterum’s dedication to developing innovative solutions to address unmet medical needs. The approval of Orlynvah underscores the importance of continued research and development in the fight against antibiotic resistance and offers a glimmer of hope for patients struggling with uUTIs.
