Iterum Therapeutics plc (Nasdaq: ITRM) announced that the U.S. Food and Drug Administration (FDA) has approved ORLYNVAH™ (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. The announcement was made on Monday, October 28, 2024. This approval marks a significant milestone as it is the first oral penem antibacterial approved for use in the U.S. and the first FDA-approved product for Iterum Therapeutics.
ORLYNVAH™ is indicated for the treatment of uUTIs caused by designated microorganisms such as Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. This approval addresses a critical need for new treatment options in the face of increasing antibiotic resistance.
Clinical Significance
The approval of ORLYNVAH™ is particularly important given the rising rates of antibiotic resistance and the limited number of new antibacterial drugs being developed. Uncomplicated UTIs are a common condition, but the increasing prevalence of multi-drug resistant bacteria makes them more difficult to treat. ORLYNVAH™ offers a new option for patients who may have limited or no other oral treatment choices.
According to Iterum Therapeutics, ORLYNVAH™ has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive, and anaerobic bacteria resistant to other antibiotics. The drug has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.
Management Commentary
Iterum Therapeutics hosted a conference call on October 28, 2024, to discuss the FDA approval. The call featured Corey Fishman, CEO, and Steve Aronin, Senior Vice President and Head of Clinical Development. During the call, they highlighted the importance of this approval in addressing the global crisis of multi-drug resistant pathogens.
About Iterum Therapeutics
Iterum Therapeutics plc is focused on developing differentiated anti-infectives to combat the global crisis of multi-drug resistant pathogens. The company's lead compound, sulopenem, is a novel penem anti-infective with both oral and IV formulations. With the FDA approval of ORLYNVAH™, Iterum is poised to make a significant impact on the treatment of serious and life-threatening infections.
