Iterum Therapeutics Receives U.S. FDA Approval of ORLYNVAH™ (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections

Core Insights - Iterum Therapeutics has received FDA approval for ORLYNVAH™, the first oral penem antibiotic in the U.S. for uncomplicated urinary tract infections (uUTIs) in adult women with limited treatment options [1][2] - ORLYNVAH™ is positioned as a novel treatment to address antimicrobial resistance and offers a new alternative in the underserved uUTI market [2][12] Company Overview - Iterum Therapeutics is focused on developing differentiated anti-infectives to combat multi-drug resistant pathogens, with ORLYNVAH™ being its first FDA-approved product [12] - The company aims to maximize stakeholder value through strategic transactions involving ORLYNVAH™ following its FDA approval [2] Product Details - ORLYNVAH™ is indicated for treating uUTIs caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women [5] - The approval was based on two pivotal Phase 3 clinical trials (SURE 1 and REASSURE), demonstrating ORLYNVAH™'s efficacy compared to ciprofloxacin and Augmentin™ [2][4] Market Context - UTIs are among the most common bacterial infections, with up to 60% of women experiencing a uUTI in their lifetime [4] - Approximately 40 million uUTI prescriptions are generated annually in the U.S., with an estimated 1% caused by pathogens resistant to commonly available oral antibiotics [4] Clinical Data - SURE 1 trial showed ORLYNVAH™'s superiority over ciprofloxacin in fluoroquinolone-resistant infections, while REASSURE trial indicated non-inferiority and statistical superiority to Augmentin™ [2] - ORLYNVAH™ was generally well tolerated in both clinical trials [2] Future Plans - The company will host a conference call on October 28, 2024, to discuss the implications of the FDA approval and future strategies [3]