FDA Approves Orlynvah for the Treatment of Uncomplicated Urinary Tract Infections
Iterum Therapeutics plc announced that the U.S. Food and Drug Administration (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.
- Orlynvah is a novel oral penem antibiotic for the treatment of uUTI. Orlynvah possesses potent activity against species of Enterobacterales including those that encode extended spectrum betalactamase (ESBL) or AmpC-type beta-lactamases that confer resistance to third generation cephalosporins.
- There are approximately 40 million uUTI prescriptions generated annually in the United States, and it is estimated approximately 1% of those infections are caused by pathogens that are resistant to all commonly available classes of oral antibiotics.
