Shots:
- The US FDA has approved Orlynvah (sulopenem etzadroxil & probenecid) to treat uUTIs in adult women, specifically addressing infections caused by E.coli, Klebsiella pneumoniae, or Proteus mirabilis, particularly when there are few or no other oral therapy available
- Approval was based on two pivotal P-III studies (SURE 1 & REASSURE) that assessed the safety & efficacy of Orlynvah vs ciprofloxacin (SURE 1) & Augmentin (REASSURE)
- The SURE 1 trial found that Orlynvah was superior to ciprofloxacin for fluoroquinolone-resistant infections, while REASSURE demonstrated both non-inferiority & statistical superiority to Augmentin among patients susceptible to that antibiotic. Both trials indicated well-tolerability
Ref: Iterum Therapeutics| Image: Iterum Therapeutics| Press Release
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