FDA approves Orlynvah (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections – Iterum Therapeutics

Iterum Therapeutics plc  announced that the FDA  has approved Iterum’s new drug application for Orlynvah (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. This is the first approved indication for Orlynvah and the first FDA-approved product for Iterum.

The FDA approval of Orlynvah was based on a clinical development program supported by a robust data package, including two pivotal, Phase III clinical trials (known as SURE 1 and REASSURE) that evaluated the safety and efficacy of Orlynvah compared to ciprofloxacin (SURE 1) and Augmentin (REASSURE) in the treatment of adult women with uUTI. SURE 1 showed superiority to ciprofloxacin in fluoroquinolone resistant infections, while REASSURE showed non-inferiority and statistical superiority to Augmentin in the Augmentin susceptible population. Orlynvh was generally well tolerated in both SURE 1 and REASSURE clinical trials.

“Multi-drug resistance in UTIs is alarmingly high and growing globally, and current treatment options are failing,” said Michael Dunne, M.D., Chief Scientific Officer of Iterum. “In particular, resistance to fluoroquinolones continues to rise. Healthcare providers and their patients urgently need new oral options to effectively treat infections in the community such as UTIs. The U.S. Food and Drug Administration (FDA) has recently strengthened existing warnings for the fluoroquinolone class and maintains that healthcare professionals should not prescribe fluoroquinolones to patients who have other treatment options for uUTI as the risks outweigh the benefits.”