FDA approves Iterum Therapeutics' antibiotic for urinary tract infections

The FDA has approved Iterum Therapeutics’ Orlynvah (sulopenem etzadroxil and probenecid), marking it as the first oral penem approved in the U.S. for the treatment of uncomplicated urinary tract infections (uUTIs).

Designed for adult women with limited alternative oral antibacterial options, orlynvah targets infections caused by E. coli, K. pneumoniae, or P. mirabilis. The approval is Iterum’s first FDA-cleared product, expanding treatment possibilities in the uUTI field.

The FDA nod was based on positive results from two phase 3 trials, SURE 1 and REASSURE, assessing orlynvah’s effectiveness against uUTI-causing bacteria. SURE 1 showed the drug’s superiority over ciprofloxacin in treating fluoroquinolone-resistant infections, while REASSURE demonstrated non-inferiority to augmentin in susceptible populations. Orlynvah was generally well tolerated in these studies, highlighting its potential for addressing antibiotic-resistant uUTI strains.

With over 40 million uUTI prescriptions issued annually in the U.S., Iterum’s new drug offers an essential alternative in a market grappling with rising antibiotic resistance.