Iterum Therapeutics plc (ITRM) announced that the U.S. Food and Drug Administration (FDA) has approved its new drug application for Orlynvah (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs). This approval is specifically for adult women who have limited or no alternative oral antibacterial treatment options, marking a significant milestone for the company and the treatment landscape of uUTIs.
This is the first approved indication for Orlynvah and the first FDA-approved product for Iterum. The drug is indicated for uUTIs caused by designated microorganisms, including Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.
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.
Clinical Significance
The approval of Orlynvah introduces a novel approach to combating antimicrobial resistance, offering an alternative treatment option for patients with uUTIs who have limited choices. As the first oral penem approved in the U.S., Orlynvah fills a critical gap in the underserved uUTI market. Iterum Therapeutics will now focus on securing a strategic transaction involving Orlynvah to maximize value for its stakeholders.
