Iterum Therapeutics plc has received FDA approval for its new drug application for Orlynvah (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. This approval is specifically for uUTIs caused by designated microorganisms such as Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, and is intended for patients who have limited or no alternative oral antibacterial treatment options.
Significance of the Approval
This marks the first approved indication for Orlynvah and the first FDA-approved product for Iterum Therapeutics. Orlynvah is also the first oral penem antibiotic approved in the United States, representing a significant advancement in the treatment of uUTIs. The drug offers a new approach to combat antimicrobial resistance, which is an increasing concern with currently available oral agents.
Management Commentary
"We are so pleased to have achieved this historic milestone and would like to thank all the patients, investigators, Iterum colleagues and Iterum consultants and vendors who participated in the development of Orlynvah. 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," said Corey Fishman, Iterum's Chief Executive Officer.
Strategic Outlook
Iterum Therapeutics is now focusing on securing a strategic transaction involving Orlynvah to maximize value for its stakeholders. With FDA approval and a clear label, the company aims to capitalize on the underserved uUTI market by providing an alternative treatment option for appropriate patients.
