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 | Image: Iterum

Related News:- European Patent Office (EPO) Grants Approval to Biogen’s Tecfidera Patent

PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com