The U.S. Food and Drug Administration (FDA) has granted approval to Iterum Therapeutics' New Drug Application (NDA) for ORLYNVAH (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. This approval introduces a new oral penem antibiotic specifically designed to combat uUTIs caused by certain resistant microorganisms, offering a potential solution to address antimicrobial resistance.
ORLYNVAH is indicated for the treatment of uUTIs in adult women caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, particularly when few or no alternative oral antibacterial treatments are available. It demonstrates activity against various Enterobacterales, including strains resistant to third-generation cephalosporins due to ESBL or AmpC-type beta-lactamases.
Clinical Trial Data
The FDA's decision was based on the results of a comprehensive clinical development program comprising two pivotal Phase III clinical trials, SURE 1 and REASSURE. These trials assessed the efficacy and safety of ORLYNVAH against ciprofloxacin and Augmentin in treating uUTI in adult women.
In the SURE 1 trial, ORLYNVAH demonstrated better outcomes than ciprofloxacin in treating fluoroquinolone-resistant infections. The REASSURE trial showed that ORLYNVAH was non-inferior and statistically superior to Augmentin in the Augmentin-susceptible population. It was well-tolerated in both trials.
Management Commentary
Iterum CEO Corey Fishman stated, "We are so pleased to have achieved this historic milestone and would like to thank all the patients, investigators, Iterum colleagues and Iterum consultants and vendors who participated in the development of ORLYNVAH. ORLYNVAH offers new hope for patients suffering from difficult-to-treat uUTIs. 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."
Iterum intends to pursue a strategic transaction involving ORLYNVAH with the goal of maximizing value for its stakeholders.
