Iterum Therapeutics plc (Nasdaq: ITRM) has received U.S. Food and Drug Administration (FDA) approval for ORLYNVAH™ (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs). This approval, announced on October 28, 2024, marks a significant advancement in combating multi-drug resistant pathogens and provides a novel oral treatment option for adult women with limited alternatives.
Addressing Unmet Needs in uUTI Treatment
ORLYNVAH™ (sulopenem etzadroxil and probenecid) is the first oral penem antibiotic to be approved in the U.S. It is indicated for uUTIs caused by designated microorganisms, including Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis. This approval is particularly crucial given the increasing resistance to existing antibiotics and the limited number of new treatments for uUTIs in recent decades.
Clinical Significance
The approval of ORLYNVAH™ represents a significant milestone for Iterum Therapeutics, as it is the company's first FDA-approved product. The drug offers a much-needed oral option for women who may have limited or no other oral antibacterial treatment choices. This is especially important in the context of rising antibiotic resistance, where effective oral treatments are increasingly scarce.
Company Commentary
Iterum Therapeutics is hosting a conference call to discuss the FDA approval and its implications. The call will feature Corey Fishman, CEO, and Steve Aronin, Senior Vice President and Head of Clinical Development. The discussion will likely cover the market potential for ORLYNVAH™ and the company's strategy for commercialization.
Conference Call Details
The conference call is scheduled for Monday, October 28, 2024, at 8:30 a.m. Eastern Daylight Time. Interested parties can join the call using the following dial-in information:
- United States: +1 833-470-1428
- International: +1 404-975-4839
- Access code: 936149
A replay of the conference call will be available on the Events & Presentations page of Iterum's website.
Iterum's Broader Strategy
Iterum Therapeutics is focused on developing differentiated anti-infectives to address the global crisis of multi-drug resistant pathogens. Sulopenem, the active ingredient in ORLYNVAH™, has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive, and anaerobic bacteria resistant to other antibiotics. Iterum has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications, highlighting the potential of this compound to address significant unmet medical needs.
