FDA Greenlights Iterum Therapeutics' UTI Antibiotic

The FDA has given the green light to Iterum Therapeutics’ Orlynvah (sulopenem etzadroxil and probenecid), marking its entry as the first oral penem available in the United States for treating uncomplicated urinary tract infections (uUTIs). This medication is particularly aimed at adult women for whom other oral antibacterial options are limited. Orlynvah targets infections caused by bacteria such as E. coli, K. pneumoniae, and P. mirabilis. This approval represents Iterum's inaugural product cleared by the FDA, opening new pathways for uUTI treatment.

The FDA's approval relied on the positive outcomes from two phase 3 clinical trials, SURE 1 and REASSURE, which evaluated Orlynvah's efficacy against the bacteria responsible for uUTIs. The SURE 1 trial demonstrated that Orlynvah was more effective than ciprofloxacin in treating infections resistant to fluoroquinolone antibiotics. Meanwhile, the REASSURE trial established that Orlynvah was equally effective as augmentin in treating susceptible populations. In both studies, Orlynvah was generally well-tolerated, underscoring its potential to combat antibiotic-resistant uUTI strains.

Annually, over 40 million prescriptions are issued for uUTIs in the United States. Iterum’s newly approved medication presents a crucial alternative in a market that is increasingly challenged by antibiotic resistance.