The US Food and Drug Administration (FDA) has approved Iterum Therapeutics' new drug application (NDA) for ORLYNVAH (sulopenem etzadroxil and probenecid) to treat uncomplicated urinary tract infections (uUTIs).
The approval introduces a new oral penem antibiotic specifically designed to combat uUTIs caused by certain resistant microorganisms.
ORLYNVAH, the first FDA-approved therapy for Iterum, 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.
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.
“With FDA approval and a clear label, we will renew our efforts to achieve a strategic transaction involving ORLYNVAH with the goal of maximising value for our stakeholders.”
The FDA's decision was based on the results of a comprehensive clinical development programme 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 SURE 1 and REASSURE trials for 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.
