The U.S. Food and Drug Administration (FDA) has approved Iterum Therapeutics’ new drug application (NDA) for ORLYNVAH (sulopenem ezadroxil and probenecid) to treat uncomplicated urinary tract infections (uUTIs).
This approval introduces a new oral penem antibiotic specifically designed to combat uUTIs caused by certain resistant microorganisms.
ORLYNVAH, Iterum’s first FDA-approved treatment, is indicated for the treatment of uUTIs in adult women caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, especially when there are few or no alternative oral antimicrobial treatments available. Applies to cases.
It is active against a variety of enteric bacteria, including third-generation cephalosporin-resistant strains due to ESBL or AmpC-type beta-lactamases.
Iterum CEO Corey Fishman said: “We are very pleased to have achieved this historic milestone and would like to thank all the patients, researchers, Iterum colleagues, Iterum consultants and vendors who participated in the development of ORLYNVAH. Bringing new hope to patients suffering from difficult-to-treat urinary tract infections.
“The introduction of novel products like ORLYNVAH is an important way to combat antimicrobial resistance to other approved oral agents and provides a potential solution for patients and physicians.
“With FDA approval and clear labeling, we renew our efforts to achieve strategic transactions involving ORLYNVAH, with the goal of maximizing value for our stakeholders.”
The FDA’s decision was based on the results of a comprehensive clinical development program consisting of two pivotal Phase III clinical trials, SURE 1 and REASSURE.
These studies evaluated the efficacy and safety of ORLYNVAH versus ciprofloxacin and augmentin in the SURE 1 and REASSURE studies for the treatment of uUTIs in adult women.
In the SURE 1 trial, ORLYNVAH showed superior results to ciprofloxacin in treating fluoroquinolone-resistant infections.
The REASSURE study showed that ORLYNVAH was non-inferior and statistically superior to Augmentin in the Augmentin-sensitive population. It was well tolerated in both trials.
“FDA Approves Iterum’s ORLYNVAH NDA for uUTI Treatment” was originally written and published. pharmaceutical technologya brand owned by GlobalData.
The information on this site is published in good faith and for general information purposes only. It is not intended to constitute advice on which you should rely, and we make no representations or warranties of any kind, express or implied, as to its accuracy or completeness. You should obtain professional or specialist advice before taking or refraining from taking any action on the basis of the content on our site.
