Iterum Therapeutics plc (ITRM) announced on Friday that the U.S. Food and Drug Administration (FDA) has approved its new drug application for Orlynvah, a combination of sulopenem etzadroxil and probenecid. This medication is intended for the treatment of uncomplicated urinary tract infections (uUTIs) caused by specific microorganisms such as Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have few or no alternative oral antibacterial treatment options available.
This marks the first FDA-approved indication for Orlynvah and is also the initial product from Iterum to receive FDA approval.
"We are thrilled to achieve this significant milestone and extend our gratitude to all the patients, investigators, Iterum team members, as well as our consultants and vendors who contributed to the development of Orlynvah," stated Corey Fishman, Chief Executive Officer of Iterum. "Orlynvah brings new hope to patients dealing with challenging uUTIs. The emergence of innovative products like Orlynvah is crucial in the fight against antimicrobial resistance to previously approved oral agents, offering potential solutions for both patients and physicians."
"As the first authorized oral penem in the U.S., Orlynvah provides an excellent alternative treatment option for suitable patients within the underserved uUTI market. Armed with FDA approval and a definitive label, we are committed to pursuing a strategic transaction involving Orlynvah to effectively maximize value for our stakeholders."
