Iterum Therapeutics plc (NASDAQ: ITRM) has received FDA approval for its new drug application for ORLYNVAH™ (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women caused by susceptible strains of Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis. This approval marks a significant advancement, as ORLYNVAH™ is the first oral penem antibiotic available in the U.S.
The FDA's decision was supported by data from two pivotal Phase 3 clinical trials. These trials compared ORLYNVAH™ to ciprofloxacin and Augmentin™. The results showed ORLYNVAH™ was superior to ciprofloxacin in treating fluoroquinolone-resistant infections. In Augmentin™-susceptible populations, ORLYNVAH™ was non-inferior and statistically superior to Augmentin™.
Clinical Efficacy and Safety
The clinical trials leading to ORLYNVAH's approval demonstrated a favorable safety profile. The most common adverse reactions reported by patients included diarrhea, nausea, vulvovaginal mycotic infection, headache, and vomiting. These adverse events were generally mild to moderate in severity.
Addressing Unmet Needs in UTI Treatment
Uncomplicated UTIs are highly prevalent, with up to 60% of women experiencing an infection during their lifetime. Approximately 40 million uUTI prescriptions are written annually in the U.S. A significant concern is the increasing resistance to commonly prescribed oral antibiotics; about 1% of these infections are caused by pathogens resistant to all commonly available oral antibiotics. ORLYNVAH™ offers a valuable alternative in these challenging cases.
Company Statements and Future Plans
Corey Fishman, CEO of Iterum, expressed gratitude to those involved in the drug's development and emphasized the importance of this approval for patients with difficult-to-treat uUTIs. The company intends to explore strategic transactions to maximize value for stakeholders. Dr. Marjorie Golden, an infectious disease expert at Yale New Haven Hospital, highlighted the importance of ORLYNVAH™ as a new treatment option in the community setting.
Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications, reflecting its commitment to combating multi-drug resistant pathogens.
