Iterum Therapeutics has received FDA approval for its new drug application for Orlynvah, indicated for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. The approval is specifically for uUTIs caused by designated microorganisms, including Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, in cases where patients have limited or no alternative oral antibacterial treatment options.
Significance of Approval
According to Iterum, this marks the first approved indication for Orlynvah and the first FDA-approved product for the company. Corey Fishman, Iterum’s Chief Executive Officer, emphasized the importance of this milestone, stating, "Orlynvah offers new hope for patients suffering from difficult-to-treat uUTIs. 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 as a Novel Treatment Option
Orlynvah (sulopenem etzadroxil/probenecid) is the first oral penem approved in the U.S., presenting an alternative treatment option for patients with uUTIs. The drug is designed to address the increasing challenge of antimicrobial resistance, offering a solution when other oral agents are ineffective.
Strategic Outlook
With the FDA approval secured, Iterum Therapeutics is now focusing on a strategic transaction involving Orlynvah. The company aims to maximize value for its stakeholders through this transaction, leveraging the drug's clear label and market potential in the underserved uUTI sector.
