Iterum Therapeutics Secures FDA Approval for Orlynvah, Breaking Two-Decade Drought in New UTI Treatments

FDA Approval:
The U.S. Food and Drug Administration (FDA) has approved Iterum Therapeutics' new drug application for Orlynvah (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs).

First Oral Penem:
Orlynvah is the first oral penem approved in the U.S. and the second FDA-approved treatment for uUTIs in the past two decades.

Indication:
Orlynvah is approved for treating uUTIs caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women with limited or no alternative oral antibacterial options.

Market Impact:
The approval of Orlynvah offers new hope for patients suffering from difficult-to-treat uUTIs and provides an alternative treatment option to combat antimicrobial resistance.

Company Response:
Iterum Therapeutics' CEO, Corey Fishman, expressed gratitude for achieving this milestone and highlighted the importance of novel products like Orlynvah in addressing antimicrobial resistance.