FDA Approves Iterum’s Novel Oral Antibiotic for Urinary Tract Infections

FDA Approves Iterum's Novel Oral Antibiotic for Urinary Tract Infections

by John Conrad| Oct 28, 2024| Member News, NewsBrief

Chicago-headquartered Iterum Therapeutics (Nasdaq: ITRM) has received U.S. Food and Drug Administration (FDA) approval for ORLYNVAH™ (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women with limited or no alternative oral antibacterial treatment options. This milestone approval marks the first oral penem antibiotic approved in the United States and only the second FDA-approved treatment for uUTIs in the past two decades.

"The introduction of novel products, like ORLYNVAH, is an important way to combat antimicrobial resistance to other approved oral agents and offers a potential solution to patients and physicians," said Corey Fishman, Iterum's Chief Executive Officer. The company anticipates a commercial launch around mid-2025.

The FDA's decision was supported by data from two pivotal Phase 3 clinical trials - SURE 1 and REASSURE. The SURE 1 trial demonstrated superiority to ciprofloxacin in treating fluoroquinolone-resistant infections, while REASSURE showed both non-inferiority and statistical superiority to Augmentin™ in susceptible populations.

UTIs represent a significant health burden, affecting up to 60% of women during their lifetime, with 40% experiencing recurrent infections. Approximately 40 million uUTI prescriptions are generated annually in the United States, with an estimated 1% of these infections caused by pathogens resistant to commonly available oral antibiotics.

The approval comes despite concerns raised during an FDA advisory committee meeting last month regarding potential off-label use and antimicrobial resistance risks. The committee specifically discussed the implications of making a carbapenem-class antibiotic available in an outpatient setting for the first time.

With the FDA approval secured, Iterum plans to pursue strategic partnerships for commercialization. The company has indicated it is actively seeking to sell or license the rights to the treatment, with CEO Fishman noting that mid-size to large pharmaceutical companies with existing prescriber relationships would be ideal partners.

The development marks an important addition to the limited arsenal of treatments for antibiotic-resistant UTIs, following the April 2024 approval of Utility Therapeutics' Pivya (pivmecillinam), which ended a two-decade drought in new uUTI treatments.

Dr. Marjorie Golden, Site Chief of Infectious Disease at St. Raphael Campus Yale New Haven Hospital, welcomed the approval, stating, "ORLYNVAH has the potential to be an important treatment alternative for use in the community."

The company will host a conference call on Monday, October 28, 2024, to discuss its commercialization strategy and next steps for bringing this novel antibiotic to market.

Press release from Iterum Therapeutics