FDA Approves Iterum’s Orlynvah for Uncomplicated UTIs, Offering New Hope for Patients with Limited Treatment Options

FDA Approval:
The U.S. Food and Drug Administration (FDA) has approved Iterum Therapeutics' Orlynvah (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women with limited or no alternative antibacterial treatment options.

Target Pathogens:
Orlynvah is specifically designed to combat uUTIs caused by E. coli, Klebsiella pneumoniae, or Proteus mirabilis, including strains resistant to third-generation cephalosporins due to ESBL or AmpC-type beta-lactamases.

Clinical Trials:
The approval is based on the results of two pivotal Phase III clinical trials, SURE 1 and REASSURE, which demonstrated Orlynvah's efficacy and safety compared to ciprofloxacin and Augmentin.

Addressing Antimicrobial Resistance:
Orlynvah offers a new oral treatment option for patients with difficult-to-treat uUTIs, addressing the growing concern of antimicrobial resistance and reducing the reliance on intravenous therapies.

Market Impact:
Orlynvah is the first oral penem antibiotic approved in the U.S. and only the second uUTI treatment approved in the past two decades, providing a significant alternative for patients and physicians.

Partnership Plans:
Iterum is now seeking a partner with sufficient resources to support an appropriate launch of Orlynvah.