Iterum Therapeutics has secured FDA approval for Orlynvah (sulopenem etzadroxil and probenecid), an oral antibiotic indicated for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. This approval marks a significant advancement in combating antimicrobial resistance and provides a new oral treatment option for infections caused by Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis.
Corey Fishman, CEO of Iterum, hailed the approval as a "historic milestone," emphasizing Orlynvah's potential to offer hope to patients with difficult-to-treat uUTIs. He noted that Orlynvah is the first oral penem approved in the U.S., representing an important tool against antimicrobial resistance to existing oral agents.
The FDA's decision was supported by data from two Phase III clinical trials. The REASSURE study demonstrated that oral sulopenem was statistically non-inferior to Augmentin (amoxicillin/clavulanate) in terms of overall response. Furthermore, Orlynvah significantly outperformed Augmentin in overall treatment success, with comparable safety outcomes between the two treatment groups.
Additional support came from the Phase III SURE 1 study, which showed that oral sulopenem was superior to ciprofloxacin in patients with quinolone-resistant infections. The SURE 1 study also reported a comparable frequency of adverse events between the Orlynvah and ciprofloxacin treatment groups.
Previous Regulatory Hurdles
Iterum previously faced regulatory challenges, receiving a Complete Response Letter from the FDA in July 2021. The regulator requested an additional trial with a different comparator drug, despite the SURE 1 study demonstrating superiority over ciprofloxacin. Iterum resubmitted its application, leading to the recent approval.
Commercialization Strategy
To facilitate the commercialization of Orlynvah, Iterum intends to "renew" its efforts to secure a strategic transaction. This move aims to maximize value for stakeholders and ensure the successful launch and distribution of the novel antibiotic.
Clinical Significance
Uncomplicated UTIs are a common infection, particularly among women, and are frequently treated with oral antibiotics. However, increasing antimicrobial resistance poses a significant challenge. Orlynvah offers a new treatment option with a different mechanism of action, potentially overcoming resistance to other commonly used oral agents. The availability of an effective oral penem antibiotic could reduce the need for intravenous therapies and help manage the growing problem of antimicrobial resistance in the outpatient setting.
