Iterum Therapeutics has received FDA approval for Orlynvah (sulopenem etzadroxil and probenecid) to treat adult women with uncomplicated urinary tract infections (uUTIs). This marks the first FDA-authorized product for Iterum Therapeutics and provides a new oral option for infections caused by bacteria including Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis, particularly in cases where alternative oral antibacterial therapies are limited. The company plans to launch the drug commercially around mid-2025.
Clinical Trial Data
The FDA's approval was based on a clinical development program that included two Phase 3 trials, SURE 1 and REASSURE. These trials evaluated the safety and efficacy of Orlynvah compared to ciprofloxacin (SURE 1) and Augmentin (REASSURE) in adult women with uUTIs.
SURE 1 demonstrated Orlynvah’s effectiveness over ciprofloxacin, especially in treating fluoroquinolone-resistant infections. REASSURE indicated that Orlynvah was non-inferior and statistically superior to Augmentin in susceptible patients. In both trials, Orlynvah was generally well tolerated.
Addressing Antimicrobial Resistance
According to Iterum Therapeutics CEO Corey Fishman, Orlynvah offers new hope for patients suffering from difficult-to-treat uUTIs and represents an important way to combat antimicrobial resistance to other approved oral agents. As the first oral penem approved in the US, Orlynvah provides an alternative treatment option for appropriate patients in the underserved uUTI market.
Strategic Plans
Iterum Therapeutics intends to pursue a strategic transaction involving Orlynvah to maximize value for its stakeholders. The company had previously announced its intention to sell or license Orlynvah’s rights in January. This approval marks only the second FDA-approved therapy for uUTIs in the past two decades, with Utility Therapeutics’ Pivya (pivmecillinam) tablets being approved earlier this year.
