Iterum Therapeutics plc (Nasdaq: ITRM) announced FDA approval of ORLYNVAH™ (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. The approval marks a significant advancement in combating multi-drug resistant pathogens.
ORLYNVAH™ (sulopenem etzadroxil and probenecid) is the first oral penem approved for use in the U.S. and the first FDA-approved product for Iterum. It is indicated for uUTIs caused by designated microorganisms, including Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis, in adult women who have limited or no alternative oral antibacterial treatment options. This approval represents only the second FDA-approved treatment for uUTIs in the past two decades.
Clinical Significance
The approval of ORLYNVAH™ addresses a critical need for new oral treatment options for uUTIs, especially in cases where resistance to commonly used antibiotics is a concern. Uncomplicated UTIs are a frequent occurrence in women, and the availability of an oral penem provides a valuable alternative when other oral agents are not suitable.
Company Statements
Iterum Therapeutics held a conference call on Monday, October 28, 2024, to discuss the FDA approval. Speakers included Corey Fishman (CEO) and Steve Aronin (Senior Vice President and Head of Clinical Development). The company is focused on delivering differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world.
About Sulopenem
Iterum Therapeutics plc is focused on delivering differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum has received approval of its NDA for ORLYNVAH™ (oral sulopenem) for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women with limited or no alternative oral antibacterial treatment options by the U.S. Food and Drug Administration and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.
